National Metrology Institute of Japan - NMIJ · PDF fileNational Metrology Institute of Japan...

Aneroid sphygmomanometer

ForManufacturing business operatorImport business operatorImport business operatorForeign manufacturing businessoperator

Alis Teles

National Metrology Institute of Japan

2013.4

IndexIndex ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 1

Introduction ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2 - 3

Type approval system flow chart ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 4

Type approval application flow chart (New/Minor change application) ・・・・・・・ 5

Type approval application procedure ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 6 – 7

Contents of application file –How to prepare 1- ・・・・・・・・・・・・・・・・・・・・・・・・・・ 8

Contents of application file –How to prepare 2- ・・・・・・・・・・・・・・・・・・・・・・・・・・ 9pp p p

Contents of application file- Outline drawing- ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 10

Contents of application file ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 11

– Cuff and construction drawing-


– Display mechanism chart and identification(plate)-

Contents of application file ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 13Contents of application file ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 13

– Test mode drawing, Block diagram, Circuit diagram,

Flow chart and Detection mechanism chart-


–Reference documents-

Adjustment of test instrument –Test mode- ・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15 - 17

Other –Changes- ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18 - 19

Change application procedure (Minor change application) ・・・・・・・・・・・・・・・・ 20

Form type type approval application ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21 - 22

Form type type approval description change application ・・・・・・・・・・・・・・・・ 23

Form type type approval minor change application ・・・・・・・・・・・・・・・・・・・・・・ 24

Form type type approval renewal application ・・・・・・・・・・・・・・・・・・・・・・・・・・ 25

Memo ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 26

Contact ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 27

Page１

IntroductionO i f ifi i d l-Overview of verification and type approval system -

For the person who shall apply the type approval for aneroid sphygmomanometer, read thefollowing overview of system and refer this guidance.

According to the Japanese Measurement Act, all of the measuring instruments defined asifi d i i t t d f b i tifi ti l ifi ti h lda specified measuring instrument used for business or certification classification should

pass the verification test..(Note1) Aneroid sphygmomanometer is classified as specifiedmeasuring instrument.In addition, it is defined that aneroid sphygmomanometer and thermometer specified asmeasuring instrument should not be transferred without verification mark.(Note2) Usuallyaneroid sphygmomanometers without verification mark cannot be seen.

In verification following is the criteria for passingIn verification, following is the criteria for passing.1. The structure conforms to technical standards defined in specified measuring instrumentverification and inspection rules (hereinafter referred to as "verification and inspectionrule”).2. The instrumental error should not exceed the verification tolerance specified by theverification and inspection rules.

All (Note3) of aneroid sphygmomanometer should be inspected and conform the technicalAll ( ) of aneroid sphygmomanometer should be inspected and conform the technicalstandards. The inspection is strict structure test including duration test. It may take longtime and financial burden. Before shipping the products, it may cause a lot of exhaustion tothe business.The type approval system for business operator of aneroid sphygmomanometer (Anotifying Manufacturing business operator (Note4)）, Import business operator, and Foreignmanufacturing business operator allows them to alleviate the hindrance.A type approval number can be indicated on approved type product of a notifyingype pp ov u be c be d c ed o pp oved ype p oduc o o y gManufacturing business operator(such as notifying Manufacturing business operator,Import business operator and Foreign manufacturing business operator) in the typeapproval system. The aneroid sphygmomanometer with type approval number isconsidered to conform the technical standards specified by the verification and inspectionrule and can take an instrumental error test without its structural test in this system.Therefore, many business operators are interested in this system. We hope this guidance ishelpful for the application.p ppNote1: Marked as Designated manufacturing business operator or Designated foreignmanufacturing business operator.

Page２

Introduction

Note2: Verification stamp and Standard conforming stamp marked by designated manufacturing business operator and designated foreign manufacturing business operator.

Note3: Aneroid sphygmomanometer other than electric aneroid sphygmomanometer can be taken non type approval inspection.

-Overview of verification and type approval system -

pp p

Note 4: The manufacturing business operator of aneroid sphygmomanometer should notify the Minister of Economy, Trade and Industry

Reference articleAct Article 2 “Definition”

E f f A i l 2 S ifi d i iEnforcement of Act article 2 Specified measuring instruments

Act Article 16 Restrictions on Use

Act article 57 Restriction on Transfer

Enforcement of Act article 15 Restriction on Transfer

Act article 71 Criteria for Passing

Verification and inspection rules article 17 Structural test method

Act article 76 type Approval pertaining to manufacturing business operator

Act article 81 type Approval, etc. Pertaining to Import business operator

Act article 89 type Approval, etc. Pertaining to Foreign manufacturing business operator

Act article 40 Notification of Business

Enforcement of Act article 6 Notification of Business

Verification and inspection rules Non type approval application methodp yp pp pp

Reference for passing criteria (Aneroid sphygmomanometer)Verification and Inspection rule article 6 Structural technical criteria

Verification and Inspection rule article 7- 15

Verification and Inspection rule article 550 – 577.

（Refer to JIS T 1115 Non invasive electric sphygmomanometer annex 1 for Electric aneroid

sphygmomanometer）

There may be other related articles. Please contact if you have any question.

Page３

T l fl hType approval system flow chart

Sales Plan

Manufacturing business operator?

Import business operator? Or Foreign manufacturing business operator?

YES

NO

NO

type approval application

Notifying manufacturing business operator

business operator?Already notify manufacturing business operator?

YES

NONO

YESEach prefecture

application

Pass?

RETURN

YESNO

DisapprovalApproval

YES

Manufacturing・

type approval markingE N D

Page４

Type approval application flow( New・Minor change application)

Inform the (tentative) Prior Consultation

Manufacturing the instrument and prepare the

type approval number

Prepare the approval drawings

Decide the model and instrument for application

Write the approval number in drawingsMake 2 sets of drawings and send

p pdocuments for application

Preliminary review OK?

YES

NO

Approval

Approval notification

Send the approval drawings

Application accepted

Pass inspection?YES

Send the approval notificationPay fees

Return the instrument inspected

Disapproval

NO

Send the receipt

This part is prepared by applicant

E N D E N D

Page５

Type approval application procedure (1/2)ype app ova app cat o p ocedu e ( / )

Application reception (Available by postal mail)

Refer to the contact

Metrology Institute (Dissemination Technology Division)

To the person in charge of sphygmomanometers

Required documents for application

●Manufacturing business operator (Import business operator) (Foreign manufacturing business operator)

type approval application

Form 7th, attached to this guide (Number of submission: 1)

Article 76 “The items to be written”1. Name and address, and in the case of a juridical person, name of its

representative

２．Business classification Enforcement of Act article 5

Appli

Sphygmomanometer Class 1

(For the business operator who manufacture aneroid

sphygmomanometer with electric detection part.)

Sphygmomanometer Class 2

(For the business operator who manufacture aneroid

h i h l i d i )

ication Docu

sphygmomanometer with non electric detection part.)

３. Name and location of factory or workplace where said specified aneroid

sphygmomanometers are manufactured.

●Construction drawings and other relevant documents

A ti l 76 i M t A t A ti l 30 i V ifi ti d i ti l

uments

Article 76 in Measurement Act, Article 30 in Verification and inspection rules

Refer to P8-14 “Construction drawings and other relevant

documents”

Page６

Continued to next page

Type approval application procedure (2/2)

●Aneroid sphygmomanometer for test

Act article 76, Verification and inspection rules article 30

The number of submission for testing: Total 3

D t il T t d (N 5) i t t 2Detail Test mode (Note5) instrument: 2

Normal mode instrument

(possible to measure the blood pressure):1

＊When any of submitted 3 instruments cannot be tested the automatic zero setting function, other instruments adjusted for test can be added.g j

＊If there are more than one of the same model instruments, we select the instrument for test.

●Application fees Article 158, Fees article 4

284,000 Yen(Send the invoice later.)142,000 Yen at reduced fee by provisory clause of application fee article 4.

＊Returning of test instrumentsAfter inspection, test instruments will be returned. However, the test

d h i ’ b di d f i Almay cause damages to the instruments’ bodies and functions. Also, one of the test instruments may not be able to be reassembled after the disassemble test. There also some risks of blemishes or scratches on the instruments after mode testing.Your cooperation and understanding is appreciated.

Note 5: Test mode The function for taking the testRefer to P１５

Page７

Contents of application filepp– How to prepare 1 -

●Construction drawings, operation principle drawings ,manufacturing process chart and other relevant documents of specified measuring instrument for test describing structure how to use use condition and manufacturing processdescribing structure, how to use, use condition and manufacturing process (Verification and inspection rules article 30)

Submission documents and drawing title

Formal document (2 copies) and reference document (1 copy)( p ) ( py)

＋

Reference documentsManufacturing process

Instruction１．Outline drawing ５．Identification(Plate)

Formal documents

Instruction

Company own inspection result data

(if available)

Three-dimensional

outline drawing

Hexahedral (6 sides)

drawing

２．Cuff drawing

６．Test mode drawing（＊）

７．Block diagram（＊）

８．Circuit diagram（＊）

９．Flow chart（＊）

10．Detection mechanism chart

＊Only electric aneroid sphygmomanometer

３．Assembly

(disassembly) drawing

４．Display mechanism chart

Page８

Contents of application fileH 2– How to prepare 2 -

Drawing form●Language: Japanese●Language: Japanese

●Size JIS PO138 A4 or A3(A3 should be folded as A4 )

●Left side binding A4縦 A4横● gMore than 20 mm margin on the left (Stapling or punching holes are not necessary)

●Dimension unit :mm

●Drawing title (Only official documents) on the bottom right cornerSequence number starting from 2 (No.1 is used for the cover sheet)

50 70mm

25-3

5mm

5-10

mm

50-70mm

図名

総紙数 ○○ 枚の内２

型式承認第Ｑ号

2

5-10mm

図名

Page９

Contents of application fileOutline drawing– Outline drawing -

１．Outline drawing


●Three-dimensional outline drawingThree-dimensional outline drawingCuff and components connection to be checked

図名

総紙数枚の内

外観図

SYS

DIA

●Hexahedral( six sides) drawingBlood pressure indicating method, dimension,

identification(plate) to be checked

SYS

DIA

Identification plate (example)

Page10

Contents of application file –Cuff and construction drawing-

２．Cuff drawing 型式承認第Ｑ号

Description of dimension, internal air bag dimension, tube size

図名

総紙数枚の内

カフ図

Inflatable bladder

３ Construction drawing３．Construction drawing(assembly drawing)

Either disassembly or assembly drawing is acceptable.

図名

総紙数枚の内


構造図

Pump, cuff, pressure sensor, deflation valve or connecting air related parts, circuit diagram for calculating plod pressure and display part to be checked.

Page11

Contents of application file Display organization chart

４．Display mechanism chartIllustrate an example of the blood pressure display.

総紙数枚の内


–Display organization chart Identification plate -

p p p yDescribe the dimension of the number on display.Illustrate the display if indicates Systolic arterial blood pressure, Diastolic arterial blood pressure and Mean arterial blood pressure. (It can be omitted if described in outline drawing).

図名表示機構図

Systolic １３５

mmHg

Diastolic ７０１３５１３５mmHg

５．Identification (plate)Describe the following items● f t i b i t

総紙数枚の内


●manufacturing business operator name●Manufacturing year●Manufacturing number●type approval number

(For instrument with electric power supply) ●Type of electric power supply and rated voltage

図名銘板図

●Type of electric power supply and rated voltage（For instrument with digital display function）

●Measurement range and scale interval

Page12

Contents of application file Test mode drawing Block diagram CircuitTest mode drawing, Block diagram, Circuit

diagram, Flow chart, Detection organization chart

６．Test ModeHow to switch into the test mode 総紙数枚の内


How to switch into the test mode and conditions

７．Block DiagramCorrelating chart from measuring to display blood pressure

図名

総紙数枚の内

受検モード図

総紙数枚の内


ブ８．Circuit diagram

Correspond to blood diagram.Describe model number of CPU and

detection part (pressure sensor)

図名ブロック図

図名

総紙数枚の内


回路図

９．Flow chartFlow chart of main routine from

power-on to displaying blood pressure, and subroutine related to measuring blood pressure

図名

総紙数枚の内


ﾌﾛｰﾁｬｰﾄp

１０．Detecting mechanism chart

Operating principle of detection part(pressure sensor), outline drawing, 図名

総紙数枚の内


検出機構図

dimension and specification

Page13

Contents of application file pp-Reference documents-

Manufacturing process chartManufacturing process chartManufacturing process before inspectionProcess symbols conform to JIS Z8206

Instruction for useInstruction for useBlood pressure measuring method and pressure sensor (transducer) type

How to use

Precaution

Risk for test (including separated visual inspection)Risk for test (including separated visual inspection)

Contents of error message function if applicable

Company own test date (If available)

Test data conforming verification and inspection rules

Page14

Adjustment of test instrument1T t d－Test mode－

What is test mode ?It is the function to set on the test mode. It is necessary to meet conditions as follows during operation.

1. The indicating mechanism displays the pressure supplied by outside.

2. Not deflate (Not release deflation valve).

3. Display zero when not pressure.

Test mode method (example)Method by softwareIt is organized by program

Method by circuit boardIt controls the valve releasing and closing by connecting lines

Method by power supplyIt controls the valve releasing and closing by supplying power directly to

the valve

Method by closing pneumatic partsMethod by closing pneumatic partsBlockconnecting inner pneumatic circuit by forceps

Applicant can select the method by themselves in any way depending on each aneroid sphygmomanometer, not only abovementioned ways. However, all of instruments need to be inspected in each prefecture. In such case, the instrument is inspected in test mode. Please consider such point. Prior meeting is welcomed.

Page15

Adjustment of test instrument２H h k h i－How to check the automatic zero

setting function－

What is the automatic zero setting function?

In the verification and inspection rules conforming with JIST1115 non-invasive

electrical sphygmomanometer, the zero setting is defined as “Work that corrects

a deviation of inner pressure of cuff reading to 0 kPa (0 mmHg) at atmospheric

pressure” . Non invasive electric sphygmomanometer should have the automatic

zero setting function. The automatic zero setting function is to set zero

Afautomatically. After the aneroid sphygmomanometer is turned on, automatic zero

setting is worked without user control.

Test (check the function) method

According to JIST T 1115 Non-invasive automatic sphygmomanometer annex 1According to JIST T 1115 Non invasive automatic sphygmomanometer annex 1

test method 4.4 , when the automatic zero setting function of aneroid

sphygmomanometer works, it is defined that the test method should check an

instrument with positive and negative (artificial) pressure instead of with

atmospheric pressure since atmospheric pressure is automatically recognized as

initial index.

Adjustment for test

For above mentioned test, the air tube should be closed for positive and negative

(artificial) pressure. After turning on the power, test mode condition could be

different by instrument type. For example, an instrument may have test mode

program. In such case, another instrument (other than test mode instrument) is

necessary for the test.

Page16

Adjustment of test instrument３T ki t f i t l l t i l d－Taking out of internal electrical power code－

（Only in case of using internal power source）

What is internal electrical power source?

They are power sources that drive aneroid

sphygmomanometer without external power. They may be

dry cell battery or cell battery. It includes charged batter.

Taking out electrical power code

The power fluctuation and duration of voltage shall be

tested with our power supply instrument (stabilized power

supply), not using the internal power supply. The powersupply), not using the internal power supply. The power

supply code should be taken out for safety power supply.

When the other method such as dummy battery and jig

supply power, it is not necessary to pull out the codes.

Pl id if h i i l d f h dPlease identify the positive electrode of the code.

＋

Page17

ＳYSDIA

Other－Changes－

Period for approval/DisapprovalVerification and inspection rules Article 71 “Inspection periods”90 days in principle (6 months at longest)

Ch f lChanges after approvalChange of description of type approval application

Article 76 in Act, “Type approval relating to manufacturing business operator”● Name and address, and in the case of a juridical person,

name of its representativename of its representative●Name and location of factory or workplace where said specified aneroid sphygmomanometer.

Form Annex P23Manufacturing business operator(Import business operator) g p ( p p )

(Foreign manufacturing business operator) description change for approved type application (need one original)

Type approval applicationVerification and inspection rules article 30 “Application”Verification and inspection rules related to calibration by the specifiedVerification and inspection rules related to calibration by the specified measuring instrument based on the Measurement Act by Advanced Industrial Science and Technology. (16 rules No.38)

For the model which is not different in critical parts from the approved type.

f b k dSome parts of test can be skipped.Application procedure same as new applicationFees 142,000 Yen Refer to Article 4 “Fees”

Page18

Other－Changes－

Minor change notificationVerification and inspection rules related to calibration by the

specified measuring instrument based on the Measurement Act byspecified measuring instrument based on the Measurement Act by

Advanced Industrial Science and Technology. (Article 16 No.38)

Notification for the minor change of approved type model which do not affect performanceNote6

Form Annex P24 “type approval minor change notification” (1)

“Structure and other related documents” explanation for the changes

(2 Copies)

In case of adding the drawings, after the page number of related document, the number starting with -2 shall be added.


Renew Model Article 83 “Valid period of approval” in the Act

Article 33 “Renew approval” in Verification and inspection rules

図名

総紙数 ○○ 枚の内２－２


外観図１

Renew approval

Attachment P 25 Form 10th

Manufacturing business operator (Import business operator) (Foreign manufacturing business operator) type approval renew application

(Need one original)

Fee 1950yen Fees article 4

Note6: Based on the inspection and verification of measurement act and specific measuring instrument rule (Rule 16 No.28), the metrology institute makes decision of impact to performance.

Page19

Change procedure (Minor change application)(Minor change application)

Prior consultation

t l

Minor change notification is OK?

YES

NO

type approval application flow

(New type approval)Approved type amendment notification

“Construction and other related documents”(2 copies)

Prepare the notification and necessary documents

YES

Company own inspection data

Send the copy of application

Receive

application

Send the receipt

This part is prepared by applicant

E N D

Page20

様式第７

For foreign manufacturing business operator, please refer tonext page.

様式第７製造事業者（輸入事業者）型式承認申請書

年月日

独立行政法人産業技術総合研究所殿

Form type 7

Manufacturing business operator (Import businessoperator) type approval application

Year / Month / Date

To The National Institute of Advanced Industrial Science and Technology (AIST)

申請者住所氏名（名称及び代表者の氏名）印

下記の特定計量器につき、計量法第７６条第１項（第８１条第１項＊１）の承認を受けたいので、申請します。


Applicant Name and address Company stamp

受けたいので、申請します。１事業の区分＊2 ２当該特定計量器を製造する工場又は事業場の名称及び所在地（製造する者の氏名又は名称及び住所＊3）

３製造事業者の届出の年月日＊４４承認を受けようとする特定計量器

1.Business category

We apply for approval of Article 79 No.1 in Measurement Act as follows.

2. Name and location of factory or workplace of manufacturingthe specified measuring instrument3.Notification Year & Month & Date of Manufacturing operator

4 Specified measuring instrument４承認を受けようとする特定計量器

種類型式又は能力手数料備考

（型式の軽微な変更の場合はその旨）

アネロイド型血電気式（電気式のみ）

円

4. Specified measuring instrument

Category Model orPerformance

Fees

圧計計量範囲目量

円

YenAneroid sphygmomanometer

Electrical (Only electrical)Measurement range Scale Interval

＊１＊３輸入事業者

＊２＊４輸入事業者は記載の必要なし

Page21

様式第７

This form is only for foreign manufacturing business operator, and attorney should be needed.

様式第７外国製造事業者型式承認申請書

年月日


Form type 7

Foreign manufacturing business operator type approvalapplication

Year / Month / Date


申請者住所氏名（名称及び代表者の氏名）

代理人住所氏名（名称及び代表者の氏名）印

Attoney Name and adress Company stamp



氏名（名称及び代表者の氏名）印

下記の特定計量器につき、計量法第８９条第１項の承認を受けたいので、申請します。

１事業の区分＊2 ２当該特定計量器を製造する工場又は事業場の名称及び所在地

We apply for approval of Article 89 No.1 in Measurement Act as follows.

2 N d l i f f k l f f i３製造事業者の届出の年月日＊3 ４承認を受けようとする特定計量器

種類型式又は能力手数料備考

（型式の軽微な変更の場合はその旨）

2. Name and location of factory or workplace of manufacturingthe specified measuring instrument

4. Specified measuring instrument

アネロイド型血圧計

電気式（電気式のみ）計量範囲目量

円


Electrical (Only electrical)Measurement range

Yen

＊２＊３記載の必要なし

Not necessary to write.

Page22

Scale Interval

製造事業者（輸入事業者）（外国製造事業者）型式承認申請書記載事項変更

届

年月日 Year / Month / Date

Manufacturing business operator (Import business operator)(Foreign manufacturingbusiness operator) description change for approved type application


届出者住所氏名（名称及び代表者の氏名）印


Notification Applicant Name and address Company stamp

下記のとおり変更があったので、計量法第７９条第１項（第８１条第３項、第

８９条第４項において準用する第７９条第１項）＊１の規定により、届け出ます。

記

We apply for change as follows by Article 79 No.1 (pursuant to Article 81 No.4, 81 No4 and 79No.1) in Measurement Act.

１．変更内容記載例）代表者の変更住所の変更社名の変更

２．変更の事由記載例）本社移転のため

1. Details of changesFor example, change of company representative,

address, or name of company.Describe old and new

2. Reasons of changeFor example, moving of headquarter記載例）本社移転のため

備考（別紙としても可）変更の発生した日型式承認リスト（承認を受け、承認の有効期間内にあるものを全て記入）

Remarks (Reference document)Change date Type approval list (All approved valid model)

型式承認リスト（承認を受け、承認の有効期間内にあるものを全て記入）

＊１第８１条第３項輸入事業者、第８９条第４項外国製造事業者

Article 81 No.2 Import business operator, Article 89 No.4 Foreign manufacturing business operator

Page23

承認型式軽微変更届出書

年月日


Type approval minor change application

Year / Month / Date



下記の特定計量器に承認型式の軽微な変更を加えたので、独立行政法人産



下記の特定計量器に承認型式の軽微な変更を加えたので、独立行政法人産業技術総合研究所が行う計量法に基づく検定、検査等及び特定標準器による校正等に関する規程（16規程第 38号）第 14条に基づいて、届出します。１承認を受けた型式（１）承認番号型式承認第 Q 号（２）種類アネロイド型血圧計

We apply for the minor change of following approved specified measuring instrument by theverification and inspection conducted by ASIT based on Article 14 in Measurement Act.

1 Approved model

(2)C t A id h t

(1) Approved model Type approval No.

（２）種類アネロイド型血圧計（３）型式又は能力電気式（＊電気式のみ）

計量範囲～ mmHg 目量 1 mmHg ２変更を加えた事項３変更箇所に係る図面

(3)Type or performanceElectric Measure range ～mmHgScale interval 1mmHg

(2)Category Aneroid sphygmomanometer

2 Details of change

３変更箇所に係る図面

図名頁番号図面の変更又は追加の別

3 Drawings related to change

Drawing title Page number

Addition or change of drawing

Page24

様式第

Form type 10

様式第 10 製造事業者（輸入事業者）（外国製造事業者）型式承認更新申請書

年月日


Manufacturing business operator (Import business operator)(Foreign business operator) type approval renewal application

Year / Month / Date


下記の特定計量器の型式の承認につき、計量法第８３条第１項（第８９条第３項において準用する第８３条第１項）＊１の更新を受けたいので申請します。


Applicant Name and adress Company stamp

項において準用する第８３条第１項）＊１の更新を受けたいので申請します。１事業の区分２当該特定計量器を製造する工場又は事業場の名称及び所在地（製造する者の氏名又は名称及び住所）

We apply the renewal of following approved specified measuring instrumentby Article 83 No.1 (pursuant to article 89, 3) in Measurement Act.

1.Business category

2. Name and location of factory or workplace of manufacturing the specifiedmeasuring instrument

３製造事業者の届出の年月日４承認を受けようとする特定計量器

種類型式承認番号

承認（及び更新）の年月日

生産数備考

アネロイド

measuring instrument3. Notification Year & Month & Date of manufacturing operator

4. Specified measuring instrument to be applied

Remarks

Number ofApproval Y M h

Type approval

Category

型血圧計

Number of instrument manufactured

Year Month Date

Type approval number


＊１第８３条製造事業者及び輸入事業者、第８９条第３項外国製造事業者

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Memo

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CContact

ContactAbout Type Approval

Aris Teles

About Type Approval

The National Institute of Advanced Industrial Science and Technology (AIST),National Metrology Institute of Japan(NMIJ) Application for Japanese Type Approvalsphygmomanometers

TEL072－751－8667FAX072－751－8693e-mail [email protected] mail nibp [email protected]： http://www.aist.go.jp

http://www.nmij.jp

1-8-31 Midorigaoka, Ikeda, Osaka 563-8577 Japanp

About feesMetrology Quality office

TEL072－751－8690FAX072 751 8698FAX072－751－8698

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