การทดสอบ Software Validation IEC 62304ศ นยเทคโนโลย อ เล...

ศูนย์เทคโนโลยีอิเล็กทรอนิกส์และคอมพิวเตอร์แห่งชาติ

การทดสอบ Software Validation IEC 62304

ดร. พนิตา เมนะเนตรห้องปฏิบัติการทดสอบซอฟต์แวร์และระบบซอฟต์แวรเ์ป็นส่วนประกอบ (SQUAT)

กลุ่มงานวิศวกรรมซอฟต์แวร์และทดสอบผลิตภัณฑ์ (SEPT) ฝ่ายสนับสนุนบริการทางวิศวกรรมและเทคโนโลยี (TSS)

ศูนย์เทคโนโลยีอิเล็กทรอนิกส์และคอมพิวเตอรแ์ห่งชาติ (NECTEC)

1

ศูนย์เทคโนโลยีอิเล็กทรอนิกส์และคอมพิวเตอร์แห่งชาติ 2

หัวข้อ (Topics)

Eco System for Quality Digital Product Related Standard in Medical Device Software Quality Management

Software verification and validation SDLC – V Model

IEC60601-1 Cl.14 vs IEC62304


Eco System for Quality Digital Productระบบนิเวศน์คุณภาพผลิตภัณฑ์ดิจิทัล

3

หน่วยที�เกี�ยวขอ้ง

MarkMarkScheme ownerScheme owner PromoterPromoter

+ Laws

Regulartorybody (RB)

Certified BodyTesting LAB


ผู้ประกอบการ(นําเข้า/ส่งออก )ผลิตภัณฑ์ดิจิทัล

+

มาตรฐาน- ต่างประเทศ- ในประเทศ

Certified Body

LAB ทดสอบที่มีมาตรฐาน

Testing LAB

หน่วยรับรอง ผู้บริโภค

มาตรฐานบังคับตปท

หมายเหตุ เส้นสีดํา – กระบวนการสากล เส้นสีแดง - กระบวนการปัจจุบัน

3

กระบวนการนําผลิตภัณฑ์ดิจิทัลที่มีคุณภาพสู่ผู้บริโภค


Related Standards in Medical Device

Ref : Medical Device Software—Software Life Cycle Processes, ANSI/AAMI/IEC 62304 : 2006 + AMD : 2015.

Cl. 14

Standards for software medical device

IEC 60601-1 : 2005 + AMD1:2012

IEC 62304 : 2006 + AMD1:2015


[ISO/IEC12207:2008] Software is

1) Instruction (computer programs) that when executed provide desired features, function, and performance

What is SOFTWARE ?

What is a Software?

Picture Ref: https://www.medicalexpo.com/prod/micrel-medical-devices/product-69404-505756.html

2) Data structure that enable the programs to adequately manipulate information

3) Descriptive information in both hard copy and virtual formsthat describes the operation and use of the programs


Software Types

User Patient

Application /

stand alone

software

Embedded

software

Sensor

Reading

Hardware

Control


Infusion Pump


Software Types

User Patient

Sensor

Reading

Hardware

Control


Infusion Pump

1

2

3 4


Software Engineering Overview – Part 1 : Problem

Delivery late High cost

Low Quality


Software Engineering Overview – Part 1 : Software Engineering

Software Engineering1) The application of a systematic, disciplined, quantifiableapproach to the development, operation, and maintenance of software; that is the application of engineering to software.2) The study of approaches as in (1).

Tools

Methods

Process

A Quality Focus


Software IEC 60601-1 Cl.14 vs IEC 62304

Ref : Medical electrical equipment—Part1 General Requirement for basic safety and essential performance, IEC 60601-1 : 2005 + AMD1: 2012

PEMS - programmable electrical medical systems

ME EQUIPMENT or an ME SYSTEM containing one or more PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS) PESS – programmable electrical SubSystems

system based on one or more central processing units, including their software and interfaces

User Patient

2.

Application /

stand alone

software

1.

Embedded

software

Sensor

Reading

Hardware

Control

PEMS

PESS 1 PESS 2

PEMS

PESS1 PESS2

PEMS PESS1


Software IEC 60601-1 Cl.14 vs IEC 62304IEC60601-1 Cl. 14


PEMS

PESS

IEC62304 does not covervalidation and final release of a medical device


Software IEC 60601-1 Cl.14 vs IEC 62304

Ref : Medical electrical equipment—Part1 General Requirement for basic safety and essential performance, IEC 60601-1 : 2005 + AMD1: 2012

Example: IEC 60601-1 : 2005 + AMD1:2012 Cl.14 Test ReportIEC 60601-1 : 2005 + AMD1:2012 Cl.14


Medical Device Process Standard IEC62304


IEC 62304 : 2006 + AMD1:2015


Software Safety Classification

Ref : Ref : Medical Device Software—Software Life Cycle Processes, ANSI/AAMI/IEC 62304 : 2006 + AMD : 2015.

• The software safety classes shall initially be assigned based on severity as follows:Class A: No injury or damage to health is possibleClass B: Non-SERIOUS INJURY is possibleClass C: Death or SERIOUS INJURY is possible”




• The software safety classes shall initially be assigned based on severity as follows:Class A: No injury or damage to health is possibleClass B: Non-SERIOUS INJURY is possibleClass C: Death or SERIOUS INJURY is possible”

Software System

(Class C)

Software Item Y

(Class C)

Software Item Z

(Class C)

Software Item W

(Class B)

Software Item X

(Class A)

PESSSOFTWARE SYSTEMIntegrated collection of SOFTWARE ITEMS organized to accomplish a specific function or set of functions

SOFTWARE ITEMAny identifiable part of a computer program,i.e., source code, object code, control code, control data, or a collection of these items


Medical Device Process Standard IEC62304: Safety Classification


Example: IEC62034 Test Report

ศูนย์เทคโนโลยีอิเล็กทรอนิกส์และคอมพิวเตอร์แห่งชาติ 18Ref : Ref : Medical Device Software—Software Life Cycle Processes, ANSI/AAMI/IEC 62304 : 2006 + AMD : 2015.

Software System

(Class C)

Software Item Y

(Class C)

Software Item Z

(Class C)

Software Item W

(Class B)

Software Item X

(Class A)

Definition : Software item Types

• Software of unknown provenance – SOUP

software that has not been developed with a known software development process or methodology, or which has unknown or no safety-related properties [off – the – self software]

• Legacy Software

software that has been developed with a known software development process or methodology, or which has unknown or no safety-related properties

- still market today



Legacy Software


Example: IEC62034 Test Report


Medical Device Process Standard IEC62304



Medical Device Process Standard IEC62304: Evidence List Example: IEC62034 Test Report

P001_RiskManagementFile 1.0 20/07/2020


Summary: Software Validation IEC62304

Eco System for Quality Digital Product (Regular body, Testing lab, Certificated body)

Related Standard in Medical Device SDLC – V Model

• Software Item, SOUP, Legacy software

• Software safety classification

• Evidence List


Web SQUAT : https://www.squat.in.th

Service

Request


อ้างอิง (Reference)

• Roger Pressman. 2009. Software Engineering: A Practitioner's Approach (7 ed.). McGraw-Hill, Inc., New York, NY, USA.

• Ivan Mistrik, Richard M. Soley, Nour Ali, John Grundy, and Bedir Tekinerdogan. 2015. Software Quality Assurance: In Large Scale and Complex Software-Intensive Systems (1st ed.). Morgan Kaufmann Publishers Inc., San Francisco, CA, USA.

• น้ําฝน อัศวเมฆิน. 2560. หลักการพื้นฐานของวิศวกรรมซอฟต์แวร์ (FUNDAMENTALS OF SOFTWARE ENGINEERING). ซีเอ็ดยูเคชัน. กรุงเทพฯ, ประเทศไทย

• https://www.istqb.org/downloads/send/51-ctfl2018/208-ctfl-2018-syllabus.html

• Medical Device Software—Software Life Cycle Processes, ANSI/AAMI/IEC 62304 : 2006 + AMD : 2015.

• Medical electrical equipment—Part1 General Requirement for basic safety and essential performance, IEC 60601-1 : 2005 + AMD1: 2012

การทดสอบ Software Validation IEC 62304ศ นยเทคโนโลย อ เล...

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