Draft List of Recognized Standards for Medical Devices · 2021. 1. 19. · 43 ISO...

Draft List of Recognized Standards for Medical Devices

This guidance document is being distributed for comment purposes only.

Draft date: 2021/01/15

Draft: List of Recognized Standards for Medical Devices | 2

Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.

Également disponible en français sous le titre : Ébauche : Normes reconnues pour les instruments médicaux

© Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2020

Publication date: April 2020

This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged.


Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents.


Table of contents 1

Changes to the List of Recognized Standards ............................................................................ 5 2

Standards Added .................................................................................................................... 5 3

Standards Updated................................................................................................................. 6 4

Standards Removed ............................................................................................................... 9 5

List of Recognized Standards ...................................................................................................... 9 6

Anaesthetic and Respiratory ................................................................................................. 9 7

Biocompatibility ................................................................................................................... 11 8

Cardiovascular ...................................................................................................................... 13 9

Contraception ....................................................................................................................... 15 10

Dental ................................................................................................................................... 15 11

Electromedical ...................................................................................................................... 17 12

General ................................................................................................................................. 22 13

In Vitro Diagnostic ................................................................................................................ 24 14

Manufacturing ...................................................................................................................... 27 15

Materials ............................................................................................................................... 29 16

Neurology ............................................................................................................................. 34 17

Ophthalmology ..................................................................................................................... 35 18

Orthopaedics ........................................................................................................................ 37 19

Radiology .............................................................................................................................. 41 20

Sterilization ........................................................................................................................... 43 21

22

23


Changes to the List of Recognized Standards 24

Standards Added 25

ISO 25539-2:2012-Ed.2.0 26

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents 27

ISO 13116:2014-Ed.1.0 28

Dentistry — Test Method for Determining Radio-Opacity of Materials 29

ISO 29022:2013-Ed.1.0 30

Dentistry — Adhesion — Notched-edge shear bond strength test 31

IEC 60601-2-1:2014-Ed.3.1 32

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety 33 and essential performance of electron accelerators in the range 1 MeV to 50 MeV 34

IEC 62366-1:2015-Ed.1.0 35

Medical devices - Part 1: Application of usability engineering to medical devices 36

IEC 62366-1/COR 1:2016 37

ASTM F2026-16 38

Standard specification for polyetheretherketone (PEEK) polymers for surgical 39 implant applications 40

ISO 11979-4:2008-Ed.2.0 41

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information 42

ISO 11979-4/Amd.1:2012 43

ISO 11979-10:2018-Ed.2.0 44

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of 45 intraocular lenses for correction of ametropia in phakic eyes 46

ISO TR 22979:2017-Ed.2.0 47

Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for 48 clinical investigation of intraocular lens design modifications 49

ASTM F2083-12 50

Standard specification for knee replacement prosthesis 51

ASTM F2346-11 52

Standard test methods for static and dynamic characterization of spinal artificial 53 discs 54

55


ASTM F3140-17 56

Standard test method for cyclic fatigue testing of metal tibial tray components of 57 unicondylar knee joint replacements 58

ASTM F543-17 59

Standard Specification and Test Methods for Metallic Medical Bone Screws 60

IEC 60601-2-45:2015-Ed.3.1 61

Medical electrical equipment – Part 2-45: Particular requirements for the basic 62 safety and essential performance of mammographic X-ray equipment and 63 mammographic stereotactic devices 64

Standards Updated 65

ISO 7199:2016-Ed.3.0 66

Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) 67

ISO 10993-1:2018-Ed.5.0 68

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk 69 management process 70

Note: Devices subject to Clause 5.3.2 may require additional testing beyond that 71 which is specified in Clause 5.3.2 72

ISO 10555-1:2013-Ed.2.0 73

Intravascular catheters - Sterile and single-use catheters - Part 1: General 74 requirements 75

ISO 10555-1/Amd.1:2017 76

ISO 25539-1:2017-Ed.2.0 77

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses 78

ISO 4049:2019-Ed.5.0 79

Dentistry – Polymer-based restorative materials 80

ISO 6872:2015-Ed.4.0 81

Dentistry – Ceramic materials 82

ISO 6872/Amd.1:2018 83

ISO 6874:2015-Ed.3.0 84

Dentistry – Polymer-based pit and fissure sealants 85

ISO 7405:2018-Ed.3.0 86

Dentistry – Evaluation of biocompatibility of medical devices used in dentistry 87

88


ISO 9917-2:2017-Ed.3.0 89

Dentistry - Water-based cements – Part 2: Resin-modified cements 90

ISO 14801:2016-Ed.3.0 91

Dentistry — Implants — Dynamic loading test for endosseous dental implants 92

ISO 22674:2016-Ed.2.0 93

Dentistry – Metallic materials for fixed and removable restorations and appliances 94

ISO 24234:2015-Ed.2.0 95

Dentistry — Dental amalgam 96

ISO/TS 11405:2015-Ed.3.0 97

Dental materials – Testing of adhesion to tooth structure 98

IEC 60601-2-22:2012-Ed.3.1 99

Medical electrical equipment – Part 2-22: Particular requirements for basic safety 100 and essential performance of surgical, cosmetic, therapeutic and diagnostic laser 101 equipment 102

ISO 14708-3:2017-Ed.2.0 103

Implants for Surgery - Active implantable medical devices -- Part 3: Implantable 104 neurostimulators 105

ISO 11979-8:2017-Ed.3.0 106

Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements 107

ASTM F1044-05 108

Standard test method for shear testing of calcium phosphate coatings and metallic 109 coatings 110

ASTM F1044-05/(R 2017) 111

ASTM F1044-05/(E 2018) 112

ASTM F1147-05 113

Standard test method for tension testing of calcium phosphate and metal coatings 114

ASTM F1147-05/(R 2017) 115

ASTM F1147-05/(E 2017) 116

ASTM F1717-18 117

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model 118

ASTM F1801-97 119

Standard practice for corrosion fatigue testing of metallic implant materials 120

ASTM F1801-97/(R 2014) 121


ASTM F2077-18 122

Test Methods for Intervertebral Body Fusion Devices 123

ASTM F2267-04 124

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral 125 Body Fusion Device under Static Axial Compression 126

ASTM F2267-04 /(R 2018) 127

ASTM F746-04 128

Standard test method for pitting or crevice corrosion of metallic surgical implant 129 materials 130

ASTM F746-04 /(R 2014) 131

ISO 14242-1:2014-Ed.3.0 132

Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and 133 displacement parameters for wear-testing machines and corresponding 134 environmental conditions for test 135

ISO 14242-1/Amd. 1: 2018 136

ISO 14242-2:2016-Ed.2.0 137

Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of 138 measurement 139

ISO 14243-2:2016-Ed.3.0 140

Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of 141 measurement 142

ISO 14243-3:2014-Ed.2.0 143

Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and 144 displacement parameters for wear-testing machines with displacement control and 145 corresponding environmental conditions for test 146

IEC 60601-2-28:2017-Ed.3.0 147

Medical electrical equipment – Part 2-28: Particular requirements for the basic 148 safety and essential performance of X-ray tube assemblies for medical diagnosis 149

IEC 60601-2-43:2017-Ed.2.1 150

Medical electrical equipment – Part 2-43: Particular requirements for the basic 151 safety and essential performance of X-ray equipment for interventional procedures 152

IEC 60601-2-43/Amd.1:2017 153

154


ISO 11135:2014-Ed.2.0 155

Sterilization of health care products – Ethylene oxide – Requirements for the 156 development, validation and routine control of a sterilization process for medical 157 devices 158

ISO 11135/Amd.1:2018 159

Standards Removed 160

ISO 9693:1999 161

Metal-ceramic dental restorative systems 162

ISO 9693/Amd.1:2005 163

IEC 60601-1-2:2007-Ed.3.0 164

Medical electrical equipment – Part 1-2: General requirements for basic safety and 165 essential performance – Collateral standard: Electromagnetic compatibility – 166 Requirements and tests 167

IEC 62366:2014-Ed.1.1 168

Medical devices – Application of usability engineering to medical devices 169

List of Recognized Standards 170

Anaesthetic and Respiratory 171

ASME PVHO-1:2007 172

Safety standard for pressure vessels for human occupancy 173

ISO 5356-1:2015-Ed.4.0 174

Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and 175 Sockets 176

ISO 5356-2:2012-Ed.3.0 177

Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw 178 threaded weight bearing connectors 179

ISO 5360:2012-Ed.3.0 180

Anaesthetic Vaporizers - Agent Specific Filling System 181


ISO 7199:2016-Ed.3.0 182

Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) 183

ISO 8359:1996-Ed.2.0 184

Oxygen Concentrators for medical use - Safety requirements 185

ISO 8359:1996-Ed.2.0/Amd.1:2012 186

ISO 80601-2-12:2011-Ed.1.0 187

Medical electrical equipment – Part 2-12: Particular requirements for basic safety 188 and essential performance of critical care ventilators 189

ISO 80601-2-12:2011-Ed.1.0/Cor.1:2011 190

ISO 80601-2-13:2011-Ed.1.0 191

Medical electrical equipment – Part 2-13: Particular requirements for basic safety 192 and essential performance of an anaesthetic workstation 193

ISO 80601-2-13:2011-Ed.1.0/Amd.1:2015 194

ISO 80601-2-55:2011-Ed.1.0 195

Medical electrical equipment – Part 2-55: Particular requirements for the basic 196 safety and essential performance of respiratory gas monitors 197

ISO 80601-2-61:2011-Ed.1.0 198

Medical electrical equipment – Part 2-61: Particular requirements for basic safety 199 and essential performance of pulse oximeter equipment 200

ISO 80601-2-72:2015-Ed.1.0 201

Medical electrical equipment – Part 2-72: Particular requirements for basic safety 202 and essential performance of home healthcare environment ventilators for 203 ventilator-dependent patients 204

205


Biocompatibility 206

ASTM F981-04 207

Standard practice for assessment of compatibility of biomaterials for surgical 208 implants with respect to effect of materials on muscle and bone 209

ISO 10993-1:2018-Ed.5.0 210

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk 211 management process 212

Note: Devices subject to Clause 5.3.2 may require additional testing beyond that 213 which is specified in Clause 5.3.2 214

ISO 10993-2:2006-Ed.2.0 215

Biological evaluation of medical devices – Part 2: Animal welfare requirements 216

ISO 10993-3:2003-Ed.2.0 217

Biological evaluation of medical devices – Part 3: Tests for genotoxicity, 218 carcinogenicity and reproductive toxicity 219

ISO 10993-4:2002-Ed.2.0 220

Biological evaluation of medical devices – Part 4: Selection of tests for interactions 221 with blood 222

ISO 10993-4:2002-Ed.2.0/Amd.1:2006 223

ISO 10993-5:2009-Ed.3.0 224

Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity 225

ISO 10993-6:2007-Ed.2.0 226

Biological evaluation of medical devices – Part 6: Tests for local effects after 227 implantation 228

ISO 10993-7:2008-Ed.2.0 229

Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization 230 residuals 231

ISO 10993-7:2008-Ed.2.0/Cor.1:2009 232


ISO 10993-9:2009-Ed.2.0 233

Biological evaluation of medical devices – Part 9: Framework for identification and 234 quantification of potential degradation products 235

ISO 10993-10:2010-Ed.3.0 236

Biological evaluation of medical devices – Part 10: Tests for irritation and skin 237 sensitization 238

ISO 10993-11:2006-Ed.2.0 239

Biological evaluation of medical devices – Part 11: Tests for systemic toxicity 240

ISO 10993-12:2007-Ed.3.0 241

Biological evaluation of medical devices – Part 12: Sample preparation and reference 242 materials 243

ISO 10993-13:2010-Ed.2.0 244

Biological evaluation of medical devices – Part 13: Identification and quantification 245 of degradation products from polymeric medical devices 246

ISO 10993-14:2001-Ed.1.0 247

Biological evaluation of medical devices – Part 14: Identification and quantification 248 of degradation products from ceramics 249

ISO 10993-15:2000-Ed.1.0 250

Biological evaluation of medical devices – Part 15: Identification and quantification 251 of degradation products from metals and alloys 252

ISO 10993-16:2010-Ed.2.0 253

Biological evaluation of medical devices – Part 16: Toxicokinetic study design for 254 degradation products and leachables 255

ISO 10993-17:2002-Ed.1.0 256

Biological evaluation of medical devices – Part 17: Establishment of allowable limits 257 for leachable substances 258

259


ISO 10993-18:2005-Ed.1.0 260

Biological evaluation of medical devices – Part 18: Chemical characterization of 261 materials 262

Cardiovascular 263

ISO 5840-1:2015-Ed.1.0 264

Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: 265 General requirements 266

ISO 5840-2:2015-Ed.1.0 267

Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - 268 Surgically implanted heart valve substitutes 269

ISO 5840-3:2013-Ed.1.0 270

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve 271 substitutes implanted by transcatheter techniques 272

ISO 5841-3:2013-Ed.3.0 273

Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for 274 implantable pacemakers 275

ISO 7198:2016-Ed.2.0 276

Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular 277 vascular grafts and vascular patches 278

ISO 10555-1:2013-Ed.2.0 279

Intravascular catheters - Sterile and single-use catheters - Part 1: General 280 requirements 281

ISO 10555-1:2013-Ed.2.0/Amd.1:2017 282

ISO 10555-3:2013-Ed.2.0 283

Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous 284 catheters 285

286


ISO 10555-4:2013-Ed.2.0 287

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation 288 catheters 289

ISO 10555-5:2013-Ed.2.0 290

Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle 291 peripheral catheters 292

ISO 11318:2002-Ed.2.0 293

Cardiac defibrillators – Connector assembly DF-1 for implantable defibrillators - 294 Dimensions and test requirements 295

ISO 14117:2012-Ed.1.0 296

Active implantable medical devices - Electromagnetic compatibility - EMC test 297 protocols for implantable cardiac pacemakers, implantable cardioverter 298 defibrillators and cardiac resynchronization devices 299

ISO 14708-2:2012-Ed.2.0 300

Implants for surgery – Active implantable medical devices – Part 2: Cardiac 301 pacemakers 302

ISO 14708-5:2010-Ed.1.0 303

Implants for surgery – Active implantable medical devices – Part 5: Circulatory 304 support devices 305

ISO 14708-6:2010-Ed.1.0 306

Implants for surgery - Active implantable medical devices - Part 6: Particular 307 requirements for active implantable medical devices intended to treat 308 tachyarrhythmia (including implantable defibrillators) 309

ISO 25539-1:2017-Ed.2.0 310

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses 311

ISO 25539-2:2012-Ed.2.0 312

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents 313

314


ISO 27186:2010-Ed.1.0 315

Active implantable medical devices – Four-pole connector system for implantable 316 cardiac rhythm management devices – Dimensional and test requirements 317

Contraception 318

ISO 4074:2002-Ed.1.0 319

Natural latex rubber condoms – Requirements and test methods 320

ISO 4074:2002-Ed.1.0/Cor.1:2003 321

ISO 4074:2002-Ed.1.0/Cor.2:2008 322

Dental 323

ISO 3107:2011-Ed.4.0 324

Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements 325

ISO 4049:2019-Ed.5.0 326

Dentistry – Polymer-based restorative materials 327

ISO 6872:2015-Ed.4.0 328

Dentistry – Ceramic materials 329

ISO 6872:2015-Ed.4.0/Amd.1:2018 330

ISO 6874:2015-Ed.3.0 331

Dentistry – Polymer-based pit and fissure sealants 332

ISO 6876:2012-Ed.3.0 333

Dental root canal sealing materials 334

ISO 6877:2006-Ed.2.0 335

Dentistry – Root-canal obturating points 336

ISO 7405:2018-Ed.3.0 337

Dentistry – Evaluation of biocompatibility of medical devices used in dentistry 338


ISO 9693-1:2012-Ed.1.0 339

Dentistry – Compatibility testing – Part 1: Metal-ceramic systems 340

ISO 9917-1:2007-Ed.2.0 341

Dentistry – Water-based cements – Part 1: Powder/liquid acid-base cements 342

ISO 9917-2:2017-Ed.3.0 343

Dentistry - Water-based cements – Part 2: Resin-modified cements 344

ISO 10271:2011-Ed.2.0 345

Dental metallic materials – Corrosion test methods for metallic materials 346

ISO 14801:2016-Ed.3.0 347

Dentistry — Implants — Dynamic loading test for endosseous dental implants 348

ISO 22674:2016-Ed.2.0 349

Dentistry – Metallic materials for fixed and removable restorations and appliances 350

ISO 22794:2007-Ed.1.0 351

Dentistry – Implantable materials for bone filling and augmentation in oral and 352 maxillofacial surgery – Contents of a technical file 353

ISO 22803:2004-Ed.1.0 354

Dentistry – Membrane materials for guided tissue regeneration in oral and 355 maxillofacial surgery – Contents of a technical file 356

ISO 24234:2015-Ed.2.0 357

Dentistry –Dental amalgam 358

ISO/TS 11405:2015-Ed.3.0 359

Dental materials – Testing of adhesion to tooth structure 360

ISO 13116:2014-Ed.1.0 361

Dentistry - Test Method for Determining Radio-Opacity of Materials 362

363


ISO 29022:2013-Ed.1.0 364

Dentistry - Adhesion - Notched-edge shear bond strength test 365

Electromedical 366

CAN/CSA C22.2 NO 60601-1-14:2014-Ed.3.0 367

Medical electrical equipment – Part 1: General requirements for basic safety and 368 essential performance 369

IEC 60529:2001-Ed.2.1 370

Degrees of protection provided by enclosures (IP Code) 371

IEC 60529:2001-Ed.2.1/Cor.1:2001 372

IEC 60529:2001-Ed.2.1/Cor.2:2007 373

IEC 60529:2001-Ed.2.1/Cor.3:2009 374

IEC 60601-1:2005-Ed.3.0 375


IEC 60601-1:2005-Ed.3.0/Cor.1:2006 378

IEC 60601-1:2005-Ed.3.0/Cor.2:2007 379

IEC 60601-1:2012-Ed.3.1 380


IEC 60601-1-2:2014-Ed.4.0 383

Medical electrical equipment – Part 1-2: General requirements for basic safety and 384 essential performance – Collateral standard: Electromagnetic disturbances – 385 Requirements and tests 386

IEC 60601-1-6:2013-Ed.3.1 387

Medical electrical equipment – Part 1-6: General requirements for basic safety and 388 essential performance – Collateral standard: Usability 389


IEC 60601-1-8:2012-Ed.2.1 390

Medical electrical equipment – Part 1-8: General requirements for basic safety and 391 essential performance – Collateral Standard: General requirements, tests and 392 guidance for alarm systems in medical electrical equipment and medical electrical 393 systems 394

IEC 60601-1-10:2007-Ed 1.0 395

Medical electrical equipment - Part 1-10: General requirements for basic safety and 396 essential performance – Collateral Standard: Requirements for the development of 397 physiologic closed-loop controllers 398

IEC 60601-1-11:2010 -Ed 1.0 399

Medical electrical equipment – Part 1-11: General requirements for basic safety and 400 essential performance – Collateral Standard: Requirements for medical electrical 401 equipment and medical electrical systems used in the home healthcare environment 402

IEC 60601-2-1:2014-Ed.3.1 403

Medical electrical equipment - Part 2-1: Particular requirements for the basic safety 404 and essential performance of electron accelerators in the range 1 MeV to 50 MeV 405

IEC 60601-2-2:2009-Ed.5.0 406

Medical electrical equipment – Part 2-2: Particular requirements for the basic safety 407 and essential performance of high frequency surgical equipment and high frequency 408 surgical accessories 409

IEC 60601-2-4:2010-Ed.3.0 410

Medical electrical equipment – Part 2-4: Particular requirements for the basic safety 411 and essential performance of cardiac defibrillators 412

IEC 60601-2-5:2009-Ed.3.0 413

Medical electrical equipment – Part 2-5: Particular requirements for the basic safety 414 and essential performance of ultrasonic physiotherapy equipment 415

416


IEC 60601-2-16:2008-Ed.3.0 417

Medical electrical equipment – Part 2-16: Particular requirements for basic safety 418 and essential performance of haemodialysis, haemodiafiltration and haemofiltration 419 equipment 420

IEC 60601-2-16:2008-Ed.3.0/Cor.1:2008 421

IEC 60601-2-18:2009-Ed.3.0 422

Medical electrical equipment – Part 2-18: Particular requirements for the basic 423 safety and essential performance of endoscopic equipment 424

IEC 60601-2-22:2012-Ed.3.1 425

Medical electrical equipment – Part 2-22: Particular requirements for basic safety 426 and essential performance of surgical, cosmetic, therapeutic and diagnostic laser 427 equipment 428

IEC 60601-2-23:2011-Ed.3.0 429

Medical electrical equipment – Part 2-23: Particular requirements for the basic 430 safety and essential performance of transcutaneous partial pressure monitoring 431 equipment 432

IEC 60601-2-24:2012-Ed.2.0 433

Medical electrical equipment – Part 2-24: Particular requirements for the basic 434 safety and essential performance of infusion pumps and controllers 435

Note: Additional accuracy testing results for flow rates below 1 ml/h may be 436 required depending on the pump's intended use 437

IEC 60601-2-25:2011-Ed.2.0 438

Medical electrical equipment – Part 2-25: Particular requirements for the basic 439 safety and essential performance of electrocardiographs 440

IEC 60601-2-26:2012-Ed.3.0 441

Medical electrical equipment – Part 2-26: Particular requirements for the basic 442 safety and essential performance of electroencephalographs 443

444


IEC 60601-2-27:2011-Ed.3.0 445

Medical Electrical Equipment – Part 2-27: Particular Requirements for the Basic 446 Safety and Essential Performance of Electrocardiographic Monitoring Equipment 447

IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012 448

IEC 60601-2-31:2008-Ed.2.0 449

Medical electrical equipment – Part 2-31: Particular requirements for the basic 450 safety and essential performance of external cardiac pacemakers with internal 451 power source 452

IEC 60601-2-31:2008-Ed.2.0/Amd.1:2011 453

IEC 60601-2-33:2010-Ed.3.0 454

Medical electrical equipment – Part 2-33: Particular requirements for the basic 455 safety and essential performance of magnetic resonance equipment for medical 456 diagnosis 457

IEC 60601-2-33:2010-Ed.3.0/Cor.1:2012 458

IEC 60601-2-34:2011-Ed.3.0 459

Medical electrical equipment – Part 2-34: Particular requirements for the basic 460 safety and essential performance of invasive blood pressure monitoring equipment 461

IEC 60601-2-47:2012-Ed.2.0 462

Medical electrical equipment – Part 2-47: Particular requirements for the basic 463 safety and essential performance of ambulatory electrocardiographic systems 464

IEC 60601-2-49:2011-Ed.2.0 465

Medical electrical equipment – Part 2-49: Particular requirements for the basic 466 safety and essential performance of multifunction patient monitoring equipment 467

IEC 60601-2-50:2009-Ed.2.0 468

Medical electrical equipment – Part 2-50: Particular requirements for the basic 469 safety and essential performance of infant phototherapy equipment 470

IEC 60601-2-50:2009-Ed.2.0/Cor.1:2010 471

472


IEC 60601-2-57:2011-Ed.1.0 473

Medical electrical equipment – Part 2-57: Particular requirements for the basic 474 safety and essential performance of non-laser light source equipment intended for 475 therapeutic, diagnostic, monitoring and cosmetic/aesthetic use 476

IEC 60825-1:2014-Ed.3.0 477

Safety of laser products - Part 1: Equipment classification and requirements 478

IEC 61000-3-2:2009-Ed.3.2 479

Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current 480 emissions (equipment input current ≤ 16 A per phase) 481

IEC 61000-3-2:2009-Ed.3.2/Cor.1:2009 482

IEC 61000-3-3:2008-Ed.2.0 483

Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage 484 changes, voltage fluctuations and flicker in public low-voltage supply systems, for 485 equipment with rated current ≤16A per phase and not subject to conditional 486 connection 487

IEC 61000-4-2:2008-Ed.2.0 488

Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement 489 techniques – Electrostatic discharge immunity test 490

IEC 61000-4-3:2010-Ed.3.2 491

Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement 492 techniques – Radiated, radio-frequency, electromagnetic field immunity test 493

IEC 61000-4-4:2012-Ed.3.0 494

Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement 495 techniques – Electrical fast transient/burst immunity test 496

IEC 61000-4-5:2005-Ed.2.0 497

Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement 498 techniques – Surge immunity test 499

IEC 61000-4-5:2005-Ed.2.0/Cor.1:2009 500


IEC 61000-4-6:2008-Ed.3.0 501

Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement 502 techniques – Immunity to conducted disturbances, induced by radio-frequency fields 503

IEC 61000-4-8:2009-Ed.2.0 504

Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement 505 techniques – Power frequency magnetic field immunity test 506

IEC 61000-4-11:2004-Ed.2.0 507

Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement 508 techniques – Voltage dips, short interruptions and voltage variations immunity tests 509

IEC 80601-2-30:2009-Ed.1.0 510

Medical electrical equipment – Part 2-30: Particular requirements for the basic 511 safety and essential performance of automated non-invasive sphygmomanometers 512

IEC 80601-2-30:2009-Ed.1.0/Cor.1:2010 513

IEC CISPR 11:2010-Ed.5.1 514

Industrial, scientific and medical equipment – Radio-frequency disturbance 515 characteristics – Limits and methods of measurement 516

ISO 14708-1:2014-Ed.2.0 517

Implants for surgery - Active implantable medical devices - Part 1: General 518 requirements for safety, marking and for information to be provided by the 519 manufacturer. 520

General 521

ASTM D4169-16 522

Standard Practice for Performance Testing of Shipping Containers and Systems 523

ASTM F1140-13 524

Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained 525 Packages 526

527


ASTM F1929-98 528

Standard test method for detecting seal leaks in porous medical packaging by dye 529 penetration 530

ASTM F1929-98:2004/(R 2004) 531

ASTM F2096-11 532

Standard Test Method for Detecting Gross Leaks in Packaging by Internal 533 Pressurization (Bubble Test) 534

ASTM F88-15 535

Standard Test Method for Seal Strength of Flexible Barrier Materials 536

IEC 62304:2015-Ed.1.1 537

Medical device software - Software life cycle processes 538

IEC 62366-1:2015-Ed.1.0 539

Medical devices –Part 1: Application of usability engineering to medical devices 540

IEC 62366-1:2015-Ed.1.0/COR 1:2016 541

ISO 10282:2002-Ed.2.0 542

Single-Use Sterile Surgical Rubber Gloves - Specification 543

ISO 11193-1:2008-Ed.2.0 544

Single-use medical examination gloves – Part 1: Specification for gloves made from 545 rubber latex or rubber solution 546

ISO 11193-1:2008-Ed.2.0/Amd.1:2012 547

ISO 11663:2009-Ed.1.0 548

Quality of dialysis fluid for haemodialysis and related therapies 549

ISO 13959:2009-Ed.2.0 550

Water for haemodialysis and related therapies 551

552


ISO 14155:2011-Ed.2.0 553

Clinical investigation of medical devices for human subjects – Good clinical practice 554

ISO 14155:2011-Ed.2.0/Cor.1:2011 555

ISO 14971:2007-Ed.2.0 556

Medical devices – Application of risk management to medical devices 557

ISO 22442-1:2015-Ed.2.0 558

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of 559 risk management 560

ISO 22442-2:2015-Ed.2.0 561

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on 562 sourcing, collection and handling 563

ISO 22442-3:2007-Ed.1.0 564

Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of 565 the elimination and/or inactivation of viruses and transmissible spongiform 566 encephalopathy (TSE) agents 567

ISO 26722:2009-Ed.1.0 568

Water treatment equipment for haemodialysis applications and related therapies 569

SAI AS 2869:2008-Ed.4.0 570

Tampons – Menstrual 571

In Vitro Diagnostic 572

CLSI C46-A2:2009-Ed.2.0 573

Blood gas and pH analysis and related measurements; Approved guideline 574

CLSI EP12-A2:2008-Ed.2.0 575

User protocol for evaluation of qualitative test performance; Approved guideline 576

577


CLSI EP14-A3:2014-Ed.3.0 578

Evaluation of Commutability of Processed Samples; Approved guideline 579

CLSI EP17-A2:2012-Ed.2.0 580

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; 581 Approved guideline 582

CLSI EP24-A2:-2011-Ed.2.0 583

Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating 584 Characteristic Curves; Approved Guideline – Second Edition 585

CLSI EP25-A:2009-Ed.1.0 586

Evaluation of stability of in vitro diagnostic reagents; Approved guideline 587

(Note: Except: Section 7.1.3) 588

CLSI EP28-A3C:2010-Ed.3.0 589

Defining, establishing, and verifying reference intervals in the clinical laboratory; 590 Approved guideline 591

CLSI EP5-A3:2014-Ed.3.0 592

Evaluation of precision of quantitative measurement procedures; Approved 593 guideline 594

CLSI EP6-A:2003-Ed.1.0 595

Evaluation of the linearity of quantitative measurement procedures: A statistical 596 approach; Approved guideline 597

CLSI EP7-A2:2005-Ed.2.0 598

Interference testing in clinical chemistry; Approved guideline 599

CLSI H15-A3:2000-Ed.3.0 600

Reference and selected procedures for the quantitative determination of 601 hemoglobin in blood; Approved standard 602

603


CLSI H20-A2:2007-Ed.2.0 604

Reference leukocyte (WBC) differential count (proportional) and evaluation of 605 instrumental methods; Approved standard 606

CLSI I/LA18-A2:2001-Ed.2.0 607

Specifications for immunological testing for infectious diseases; Approved guideline 608

CLSI I/LA21-A2:2008-Ed.2.0 609

Clinical evaluation of immunoassays; Approved guideline 610

CLSI MM01-A3:2012-Ed.3.0 611

Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline 612

CLSI MM06-A2:2010-Ed.2.0 613

Quantitative Molecular Methods for Infectious Diseases 614

CLSI MM12-A:2006-Ed.1.0 615

Diagnostic nucleic acid microarrays; Approved guideline 616

CLSI MM13-A:2005-Ed.1.0 617

Collection, transport, preparation, and storage of specimens for molecular methods; 618 Approved guideline. Note: Except: Section 6.1.1 619

CLSI MM16-A:2006-Ed.1.0 620

Use of external RNA controls in gene expression assays; Approved guideline 621

CLSI MM17-A:2008-Ed.1.0 622

Verification and validation of multiplex nucleic acid assays; Approved guideline 623

CLSI POCT14-A:2004-Ed.1.0 624

Point-of-care monitoring of anticoagulation therapy; Approved guideline 625

626


IEC 61010-1:2010-Ed.3.0 627

Safety requirements for electrical equipment for measurement, control, and 628 laboratory use – Part 1: General requirements 629

IEC 61010-1:2010-Ed.3.0/Cor.1:2011 630

IEC 61010-1:2010-Ed.3.0/Cor.2:2013 French Only/Version Francaise 631

IEC 61010-2-101:2015-Ed.2.0 632

Safety requirements for electrical equipment for measurement, control, and 633 laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) 634 medical equipment 635

IEC 61326-1:2012-Ed.2.0 636

Electrical equipment for measurement, control and laboratory use – EMC 637 requirements Part 1: General requirements 638

IEC 61326-2-6:2012-Ed.2.0 639

Electrical equipment for measurement, control and laboratory use – EMC 640 requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical 641 equipment 642

ISO 15197:2013-Ed.2.0 643

In vitro diagnostic test systems – Requirements for blood-glucose monitoring 644 systems for self-testing in managing diabetes mellitus 645

ISO 23640:2011-Ed.1.0 646

In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic 647 reagents 648

Manufacturing 649

ISO 13408-1:2008-Ed.2.0 650

Aseptic processing of health care products - Part 1 : General requirements 651

ISO 13408-2:2003-Ed.1.0 652

Aseptic processing of health care products - Part 2 : Filtration 653


ISO 13408-3:2006-Ed.1.0 654

Aseptic processing of health care products - Part 3 : Lyophilization 655

ISO 13408-4:2005-Ed.1.0 656

Aseptic processing of health care products - Part 4 : Clean-in-place technologies 657

ISO 13408-5:2006-Ed.1.0 658

Aseptic processing of health care products - Part 5 : Sterilization in place 659

ISO 13408-6:2005-Ed.1.0 660

Aseptic processing of health care products - Part 6 : Isolator systems 661

ISO 13408-7:2012-Ed.1.0 662

Aseptic processing of health care products - Part 7 : Alternative processes for 663 medical devices and combination products 664

ISO 14644-1:1999-Ed.1.0 665

Cleanrooms and associated controlled environments - Part 1: Classification of air 666 cleanliness 667

ISO 14644-2:2000-Ed.1.0 668

Cleanrooms and associated controlled environments - Part 2: Specifications for 669 testing and monitoring to prove continued compliance with ISO 14644-1 670

ISO 14644-3:2005-Ed.1.0 671

Cleanrooms and associated controlled environments - Part 3: Test methods 672

ISO 14644-4:2001-Ed.1.0 673

Cleanrooms and associated controlled environments - Part 4: Design, Construction 674 and Start Up 675

ISO 14644-5:2004-Ed.1.0 676

Cleanrooms and associated controlled environments - Part 5: Operations 677

678


ISO 14644-6:2007-Ed.1.0 679

Cleanrooms and associated controlled environments - Part 6: Vocabulary 680

ISO 14644-7:2004-Ed.1.0 681

Cleanrooms and associated controlled environments - Part 7: Separative devices 682 (clean air hoods, glove boxes, isolators and mini-environments) 683

ISO 14644-8:2013-Ed.2.0 684

Cleanrooms and associated controlled environments - Part 8: Classification of air 685 cleanliness by chemical concentration (ACC) 686

ISO 14644-9:2012-Ed.1.0 687

Cleanrooms and associated controlled environments - Part 9: Classification of 688 surface cleanliness by particle concentration 689

ISO 14644-10:2013-Ed.1.0 690

Cleanrooms and associated controlled environments - Part 10: Classification of 691 surface cleanliness by chemical concentration 692

ISO 14698-1:2003-Ed.1.0 693

Cleanrooms and associated controlled environments - Biocontamination control - 694 Part 1: General principles and methods 695

ISO 14698-2:2003-Ed.1.0 696

Cleanrooms and associated controlled environments - Biocontamination control - 697 Part 2: Evaluation and interpretation of biocontamination data 698

Materials 699

ASTM F1088-04a 700

Standard specification for beta-tricalcium phosphate for surgical implantations 701

ASTM F1088-04a:2010/(R 2010)ASTM F1091-08 702

Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy 703 surgical fixation wire (UNS R30605) 704


ASTM F1108-04 705

Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical 706 implants (UNS R56406) 707

ASTM F1108-04:2009/(R 2009) 708

ASTM F1295-05 709

Standard specification for wrought titanium-6 aluminum-7 niobium alloy for surgical 710 implant applications (UNS R56700) 711

ASTM F1314-07 712

Standard specification for wrought nitrogen strengthened 22chromium-13nickel-713 5manganese-2.5molybdenum stainless steel alloy bar and wire for surgical implants 714 (UNS S20910) 715

ASTM F1350-08 716

Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless 717 steel surgical fixation wire (UNS S31673) 718

ASTM F136-12 719

Standard specification for wrought titanium-6aluminum-4vanadium ELI (Extra Low 720 Interstitial) alloy for surgical implant applications (UNS R56401) 721

ASTM F138-08 722

Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless 723 steel bar and wire for surgical implants (UNS S31673) 724

ASTM F139-08 725

Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless 726 steel sheet and strip for surgical implants (UNS S31673) 727

ASTM F1472-08 728

Standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical 729 implant applications (UNS R56400) 730

731


ASTM F1537-08 732

Standard specification for wrought cobalt-28 chromium-6 molybdenum alloy for 733 surgical implants (UNS R31537, UNS R31538, and UNS R31539) 734

ASTM F1580-12 735

Standard specification for titanium and titanium-6aluminum-4vanadium alloy 736 powders for coatings of surgical implants 737

ASTM F1586-08 738

Standard specification for wrought nitrogen strengthened 21chromium-10nickel-739 3manganese-2.5molybdenum stainless steel bar for surgical implants (UNS S31675) 740

ASTM F1713-08 741

Standard specification for wrought titanium-13niobium-13zirconium alloy for 742 surgical implant applications (UNS R58130) 743

ASTM F2026-16 744

Standard specification for polyetheretherketone (PEEK) polymers for surgical 745 implant applications 746

ASTM F2565-06 747

Standard guide for extensively irradiation-crosslinked ultra-high molecular weight 748 polyethylene fabricated forms for surgical implant applications 749

ASTM F560-08 750

Standard specification for unalloyed tantalum for surgical implant applications (UNS 751 R05200, UNS R05400) 752

ASTM F562-07 753

Standard specification for wrought 35cobalt-35nickel-20chromium-10molybdenum 754 alloy for surgical implant applications (UNS R30035) 755

ASTM F620-06 756

Standard specification for alpha plus beta titanium alloy forgings for surgical 757 implants 758

759


ASTM F621-08 760

Standard specification for stainless steel forgings for surgical implants 761

ASTM F648-07 762

Standard specification for ultra-high-molecular weight polyethylene powder and 763 fabricated form for surgical implants 764

ASTM F648-07:2007/(e 2007)ASTM F67-06 765

Standard specification for unalloyed titanium for surgical implant applications (UNS 766 R50250, UNS R50400, UNS R50550, UNS R50700) 767

ASTM F688-05 768

Standard specification for wrought cobalt-35 nickel-20 chromium-10 molybdenum 769 alloy plate, sheet, and foil for surgical implants (UNS R30035) 770

ASTM F75-12 771

Standard specification for cobalt-28chromium-6molybdenum alloy castings and 772 casting alloy for surgical implants (UNS R30075) 773

ASTM F799-11 774

Standard specification for cobalt-28chromium-6molybdenum alloy forgings for 775 surgical implants (UNS R31537, R31538, R31539) 776

ASTM F899-12 777

Standard specification for wrought stainless steel for surgical instruments 778

ASTM F90-09 779

Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy 780 for surgical implant applications (UNS R30605) 781

ASTM F961-08 782

Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy 783 forgings for surgical implants (UNS R30035) 784

785


ISO 3826-1:2003-Ed.1.0 786

Plastic collapsible containers for human blood and blood components – Part 1: 787 Conventional containers 788

ISO 5832-1:2007-Ed.4.0 789

Implants for Surgery – Metallic materials – Part 1: Wrought stainless steel 790

ISO 5832-1:2007-Ed.4.0/Corr1:2008 791

ISO 5832-2:1999-Ed.3.0 792

Implants for surgery – Metallic materials – Part 2: Unalloyed titanium 793

ISO 5832-3:1996-Ed.3.0 794

Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-795 vanadium alloy 796

ISO 5832-4:1996-Ed.2.0 797

Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum 798 casting alloy 799

ISO 5832-5:2005-Ed.3.0 800

Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-801 tungsten-nickel alloy 802

ISO 5832-6:1997-Ed.2.0 803

Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-804 molybdenum alloy 805

ISO 5832-9:2007-Ed.2.0 806

Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless 807 steel 808

ISO 5832-11:1994-Ed.1.0 809

Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 810 7-niobium alloy 811

812


ISO 5832-12:2007-Ed.2.0 813

Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-814 molybdenum alloy 815

ISO 5832-12:2007-Ed.2.0/Cor.1:2008 816

ISO 5834-2:2011-Ed.4.0 817

Implants for surgery – Ultra-high molecular weight polyethylene – Part 2: Moulded 818 forms 819

ISO 6474-1:2010-Ed.1.0 820

Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high 821 purity alumina 822

ISO 6474-2:2012-Ed.1.0 823

Implants for surgery - Ceramic materials - Part 2: Composite materials based on a 824 highpurity alumina matrix with zirconia reinforcement 825

ISO 7153-1:1991-Ed.2.0 826

Surgical instruments – Metallic materials – Part 1: Stainless steel 827

ISO 7153-1:1991-Ed.2.0/Amd.1:1999 828

ISO 13402:1995-Ed.1.0 829

Surgical and dental hand instruments – Determination of resistance against 830 autoclaving, corrosion and thermal exposure 831

ISO 13782:1996-Ed.1.0 832

Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant 833 applications 834

Neurology 835

IEC 60601-2-10:2012-Ed.2.0 836

Medical electrical equipment – Part 2-10: Particular requirements for the basic 837 safety and essential performance of nerve and muscle stimulators 838

839


ISO 14708-3:2017-Ed.2.0 840

Implants for Surgery - Active implantable medical devices -- Part 3: Implantable 841 neurostimulators 842

843

ISO 14708-7:2013-Ed.1.0 844

Implants for surgery - Active implantable medical devices - Part 7: Particular 845 requirements for cochlear implant systems 846

Ophthalmology 847

ANSI Z80.7:2002 848

Ophthalmic optics – Intraocular lenses 849

ISO 11979-1:2006-Ed.2.0 850

Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary 851

ISO 11979-2:2014-Ed.2.0 852

Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test 853 methods 854

ISO 11979-3:2006-Ed.2.0 855

Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test 856 methods 857

ISO 11979-4:2008-Ed.2.0 858

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information 859

ISO 11979-4:2008-Ed.2.0/Amd.1:2012 860

ISO 11979-5:2006-Ed.2.0 861

Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility 862

ISO 11979-6:2007-Ed.2.0 863

Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability 864

865


ISO 11979-7:2006-Ed.2.0 866

Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations 867

ISO 11979-7:2006-Ed.2.0/Amd.1:2012 868

ISO 11979-8:2017-Ed.3.0 869

Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements 870

ISO 11979-10:2018-Ed.2.0 871

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of 872 intraocular lenses for correction of ametropia in phakic eyes 873

ISO TR 22979:2017-Ed.2.0 874

Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for 875 clinical investigation of intraocular lens design modifications 876

ISO 11980:2009-Ed.2.0 877

Ophthalmic optics – Contact lenses and contact lens care products – Guidance for 878 clinical investigations 879

ISO 15004-2:2007-Ed.1.0 880

Ophthalmic instruments – Fundamental requirements and test methods – Part 2: 881 Light hazard protection 882

ISO 18369-1:2006-Ed.1.0 883

Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and 884 recommendations for labelling specifications 885

ISO 18369-1:2006-Ed.1.0/Amd.1:2009 886

ISO 18369-2:2006-Ed.1.0 887

Ophthalmic optics – Contact lenses – Part 2: Tolerances 888

ISO 18369-3:2006-Ed.1.0 889

Ophthalmic optics – Contact lenses – Part 3: Measurement methods 890

891


ISO 18369-4:2006-Ed.1.0 892

Ophthalmic optics – Contact lenses – Part 4: Physicochemical properties of contact 893 lens materials 894

IEC 80601-2-58:2016-Ed.2.1 895

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety 896 and essential performance of lens removal devices and vitrectomy devices for 897 ophthalmic surgery 898

Orthopaedics 899

ASTM F1044-05 900

Standard test method for shear testing of calcium phosphate coatings and metallic 901 coatings 902

ASTM F1044-05:2005/(R 2017) 903

ASTM F1044-05:2005/(E 2018) 904

ASTM F1089-10 905

Standard test method for corrosion of surgical instruments 906

ASTM F1147-05 907

Standard test method for tension testing of calcium phosphate and metal coatings 908

ASTM F1147-05:2005/(R 2017) 909

ASTM F1147-05:2005/(E 2017) 910

ASTM F1160-14 911

Standard test method for shear and bending fatigue testing of calcium phosphate 912 and metallic medical and composite calcium phosphate/metallic coatings 913

ASTM F1377-13 914

Standard specification for cobalt-28chromium-6molybdenum powder for coating of 915 orthopedic Implants (UNS R30075) 916

917


ASTM F1609-08 918

Standard Specification for calcium phosphate coatings for implantable materials 919

ASTM F1609-08:2008/(R 2014) 920

ASTM F1717-18 921

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model 922

ASTM F1798-13 923

Standard Test Method for evaluating the static and fatigue properties of 924 interconnection mechanisms and subassemblies used in spinal arthrodesis implants 925

ASTM F1800-12 926

Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total 927 Knee Joint Replacements 928

ASTM F1801-97 929

Standard practice for corrosion fatigue testing of metallic implant materials 930

ASTM F1801-97:1997/(R 2014) 931

ASTM F1829-17 932

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism 933 in Shear 934

ASTM F1875-98 935

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip 936 Femoral Head-Bore and Cone Taper Interface 937

ASTM F1875-98:2014/(R 2014) 938

ASTM F2028-14 939

Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or 940 Disassociation 941

ASTM F2077-18 942

Test Methods for Intervertebral Body Fusion Devices 943


ASTM F2267-04 944

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral 945 Body Fusion Device under Static Axial Compression 946

ASTM F2267-04:2004/(R 2018) 947

ASTM F2346-11 948

Standard test methods for static and dynamic characterization of spinal artificial 949 discs 950

ASTM F2582-14 951

Standard Test Method for Impingement of Acetabular Prostheses 952

ASTM F2665-09 953

Standard Specification for Total Ankle Replacement Prosthesis 954

ASTM F2665-09:2014/(R 2014) 955

ASTM F2943-14 956

Standard Guide for Presentation of End User Labeling Information for 957 Musculoskeletal Implants 958

ASTM F3140-17 959

Standard test method for cyclic fatigue testing of metal tibial tray components of 960 unicondylar knee joint replacements 961

ASTM F543-17 962

Standard Specification and Test Methods for Metallic Medical Bone Screws 963

ASTM F746-04 964

Standard test method for pitting or crevice corrosion of metallic surgical implant 965 materials 966

ASTM F746-04:2004/(R 2014) 967

ASTM F86-13 968

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants 969

970


ASTM F897-02 971

Standard test method for measuring fretting corrosion of osteosynthesis plates and 972 screws 973

ASTM F897-02:2002/(R 2013) 974

ASTM F983-86 975

Standard practice for permanent marking of orthopaedic implant components 976

ASTM F983-86:1986/(R 2013) 977

ISO 5838-1:2013-Ed.3.0 978

Implants for surgery - Metallic skeletal pins and wires Part 1: General requirements 979

ISO 5838-2:1991-Ed.1.0 980

Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – 981 Dimensions 982

ISO 5838-3:1993-Ed.1.0 983

Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires 984

ISO 7153-1:1991-Ed.2.0 985

Surgical instruments – Metallic materials – Part 1: Stainless steel 986

ISO 7153-1:1991-Ed.2.0/Amd.1:1999 987

ISO 7206-4:2010-Ed.3.0 988

Implants for surgery partial and total hip joint prostheses – Part 4: Determination of 989 endurance properties and performance of stemmed femoral components 990

ISO 7206-6:2013-Ed.2.0 991

Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance 992 properties testing and performance requirements of neck region of stemmed 993 femoral components 994

995


ISO 9583:1993-Ed.1.0 996

Implants for surgery – Non-destructive testing – Liquid penetrant inspection of 997 metallic surgical implants 998

ISO 14242-1:2014-Ed.3.0 999

Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and 1000 displacement parameters for wear-testing machines and corresponding 1001 environmental conditions for test 1002

ISO 14242-1:2014-Ed.3.0/Amd. 1: 2018 1003

ISO 14242-2:2016-Ed.2.0 1004

Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of 1005 measurement 1006

ISO 14243-1:2009-Ed.2.0 1007

Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and 1008 displacement parameters for wear-testing machines with load control and 1009 corresponding environmental conditions for test 1010

ISO 14243-2:2016-Ed.3.0 1011

Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of 1012 measurement 1013

ISO 14243-3:2014-Ed.2.0 1014

Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and 1015 displacement parameters for wear-testing machines with displacement control and 1016 corresponding environmental conditions for test 1017

ISO 14630:2012-Ed.4.0 1018

Non-active surgical implants - General requirements 1019

Radiology 1020

AIUM/NEMA UD 2:2004 1021

Acoustic output measurement standard for diagnostic ultrasound equipment 1022

AIUM/NEMA UD 2:2004/(R 2009) 1023


AIUM/NEMA UD 3:2004 1024

Standard for real-time display of thermal and mechanical acoustic output indices on 1025 diagnostic ultrasound equipment 1026

IEC 60601-1-3:2013-Ed.2.1 1027

Medical electrical equipment – Part 1-3: General requirements for basic safety and 1028 essential performance – Collateral Standard: Radiation protection in diagnostic X-ray 1029 equipment 1030

IEC 60601-2-28: 2017-Ed.3.0 1031

Medical electrical equipment – Part 2-28: Particular requirements for the basic 1032 safety and essential performance of X-ray tube assemblies for medical diagnosis 1033

IEC 60601-2-37:2015-Ed.2.1 1034

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety 1035 and essential performance of ultrasonic medical diagnostic and monitoring 1036 equipment 1037

IEC 60601-2-43:2017-Ed.2.1 1038

Medical electrical equipment – Part 2-43: Particular requirements for the basic 1039 safety and essential performance of X-ray equipment for interventional procedures 1040

IEC 60601-2-43:2017-Ed.2.1/Amd.1:2017 1041

IEC 60601-2-44:2016-Ed.3.2 1042

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety 1043 and essential performance of X-ray equipment for computed tomography 1044

IEC 60601-2-45:2015-Ed.3.1 1045

Medical electrical equipment – Part 2-45: Particular requirements for the basic 1046 safety and essential performance of mammographic X-ray equipment and 1047 mammographic stereotactic devices 1048

IEC 60601-2-54:2015-Ed.1.0 1049

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety 1050 and essential performance of X-ray equipment for radiography and radioscopy 1051

1052


Sterilization 1053

ASTM F1980-07 1054

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices 1055

CAN/CSA Z17665-1-09:2009-Ed.1.0 1056

Sterilization of health care products – Moist heat Part 1: Requirements for the 1057 development, validation and routine control of a sterilization process for medical 1058 devices 1059

ISO 11135:2014-Ed.2.0 1060

Sterilization of health care products – Ethylene oxide – Requirements for the 1061 development, validation and routine control of a sterilization process for medical 1062 devices 1063

ISO 11135:2014-Ed.2.0/Amd.1:2018 1064

ISO 11137-1:2006-Ed.1.0 1065

Sterilization of health care products – Radiation – Part 1: Requirement for 1066 development, validation and routine control of a sterilization process for medical 1067 devices 1068

ISO 11137-2:2013-Ed.3.0 1069

Sterilization of health care products – Radiation – Part 2: Establishing the 1070 sterilization dose 1071

ISO 11137-3:2006-Ed.1.0 1072

Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric 1073 aspects 1074

ISO 11138-1:2006-Ed.2.0 1075

Sterilization of health care products – Biological indicators – Part 1: General 1076

ISO 11138-2:2006-Ed.2.0 1077

Sterilization of health care products – Biological indicators – Part 2: Biological 1078 indicators for ethylene oxide sterilization processes 1079

1080


ISO 11138-3:2006-Ed.2.0 1081

Sterilization of health care products – Biological indicators – Part 3: Biological 1082 indicators for moist heat sterilization processes 1083

ISO 11607-1:2006-Ed.1.0 1084

Packaging for terminally sterilized medical devices – Part 1: Requirements for 1085 materials, sterile barrier systems and packaging systems 1086

ISO 11607-2:2006-Ed.1.0 1087

Packaging for terminally sterilized medical devices – Part 2: Validation requirements 1088 for forming, sealing and assembly processes 1089

ISO 11737-1:2006-Ed.2.0 1090

Sterilization of medical devices – Microbiological methods – Part 1: Determination of 1091 population of microorganisms on products 1092

ISO 11737-1:2006-Ed.2.0/Cor.1:2007 1093

ISO 14160:2011-Ed.2.0 1094

Sterilization of health care products - Liquid chemical sterilizing agents for single-use 1095 medical devices utilizing animal tissues and their derivatives - Requirements for 1096 characterization, development, validation and routine control of a sterilization 1097

ISO 14937:2009-Ed.2.0 1098

Sterilization of health care products – General requirements for characterization of a 1099 sterilizing agent and the development, validation and routine control of a 1100 sterilization process for medical devices 1101

ISO 17664:2004-Ed.1.0 1102

Sterilization of medical devices – Information to be provided by the manufacturer 1103 for the processing of resterilizable medical devices 1104

ISO 17665-1:2006-Ed.1.0 1105

Sterilization of health care products – Moist heat Part 1: Requirements for the 1106 development, validation and routine control of a sterilization process for medical 1107 devices 1108

1109

Draft List of Recognized Standards for Medical Devices · 2021. 1. 19. · 43 ISO...

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Transcript of Draft List of Recognized Standards for Medical Devices · 2021. 1. 19. · 43 ISO...