型式承認申請ガイド２００８．４改訂版

Transcription

1 Aneroid sphygmomanometer Alis Teles Application for Manufacturing business operator Import business operator Foreign manufacturing business operator National Metrology Institute of Japan

2 Index Index 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 2-9 Contents of application file- Outline drawing- 10 Contents of application file 11 Cuff and construction drawing- Contents of application file 12 Display mechanism chart and identification(plate)- Contents of application file 13 Test mode drawing, Block diagram, Circuit diagram, Flow chart and Detection mechanism chart- Contents of application file 14 Reference documents- Adjustment of test instrument Test mode Other Changes Change application procedure (Minor change application) 20 Form type type approval application 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

3 -Overview of verification and type approval system - For the person who shall apply the type approval for aneroid sphygmomanometer, read the following overview of system and refer this guidance. According to the Japanese Measurement Act, all of the measuring instruments defined as a specified measuring instrument used for business or certification classification should pass the verification test..(note1) Aneroid sphygmomanometer is classified as specified measuring instrument. In addition, it is defined that aneroid sphygmomanometer and thermometer specified as measuring instrument should not be transferred without verification mark.(note2) Usually aneroid sphygmomanometers without verification mark cannot be seen. In verification, following is the criteria for passing. 1. The structure conforms to technical standards defined in specified measuring instrument verification and inspection rules (hereinafter referred to as "verification and inspection rule ). 2. The instrumental error should not exceed the verification tolerance specified by the verification and inspection rules. All (Note3) of aneroid sphygmomanometer should be inspected and conform the technical standards. The inspection is strict structure test including duration test. It may take long time and financial burden. Before shipping the products, it may cause a lot of exhaustion to the business. The type approval system for business operator of aneroid sphygmomanometer (A notifying Manufacturing business operator (Note4) ), Import business operator, and Foreign manufacturing business operator allows them to alleviate the hindrance. A type approval number can be indicated on approved type product of a notifying Manufacturing business operator(such as notifying Manufacturing business operator, Import business operator and Foreign manufacturing business operator) in the type approval system. The aneroid sphygmomanometer with type approval number is considered to conform the technical standards specified by the verification and inspection rule 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 is helpful for the application. Note1: Marked as Designated manufacturing business operator or Designated foreign manufacturing business operator. Page2

4 -Overview of verification and type approval system - 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. Note 4: The manufacturing business operator of aneroid sphygmomanometer should notify the Minister of Economy, Trade and Industry Reference article Act Article 2 Definition Enforcement 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 method 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 (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

5 Type approval system flow chart Sales Plan Manufacturing business operator? NO NO Each prefecture Notifying manufacturing business operator YES Already notify manufacturing business operator? YES Import business operator? Or Foreign manufacturing business operator? YES NO type approval application RETURN Pass? YES NO Approval Disapproval Manufacturing type approval marking E N D Page4

6 Type approval application flow ( New Minor change application) Prior Consultation Decide the model and instrument for application Inform the (tentative) type approval number NO Manufacturing the instrument and prepare the documents for application Preliminary review OK? YES Prepare the approval drawings Approval Write the approval number in drawings Make 2 sets of drawings and send Application accepted Pay fees Pass inspection? NO YES Send the approval notification Approval notification Send the approval drawings Return the instrument inspected Disapproval Send the receipt E N D E N D This part is prepared by applicant Page5

7 Type approval application procedure (1/2) Application reception (Available by postal mail) Refer to the contact Metrology Institute (Dissemination Technology Division) To the person in charge of sphygmomanometers Application Documents Required documents for application Manufacturing business operator (Import business operator) (Foreign manufacturing business operator) type approval application Form 7 th, 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 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 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 Article 76 in Measurement Act, Article 30 in Verification and inspection rules Refer to P8-14 Construction drawings and other relevant documents Continued to next page Page6

8 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 Detail 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. *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 instruments After inspection, test instruments will be returned. However, the test may 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 test Refer to P15 Page7

9 Contents of application file 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 process (Verification and inspection rules article 30) Submission documents and drawing title Formal document (2 copies) and reference document (1 copy) + Formal documents Reference documents 1.Outline drawing Three-dimensional outline drawing Hexahedral (6 sides) drawing 2.Cuff drawing 3.Assembly (disassembly) drawing 4.Display mechanism chart Manufacturing process 5.Identification(Plate) Instruction 6.Test mode drawing(*) Company own inspection result data 7.Block diagram(*) (if available) 8.Circuit diagram(*) 9.Flow chart(*) 10.Detection mechanism chart *Only electric aneroid sphygmomanometer Page8

10 25-35mm 5-10mm Contents of application file How to prepare 2 - Drawing form Language: Japanese Size JIS PO138 A4 or A3 (A3 should be folded as A4 ) Left side binding A4 縦 More than 20 mm margin on the left (Stapling or punching holes are not necessary) A4 横 Dimension unit :mm Drawing title (Only official documents) on the bottom right corner Sequence number starting from 2 (No.1 is used for the cover sheet) 50-70mm 型式承認第 Q 号 総紙数 枚の内 2 図名 5-10mm Page9

11 Contents of application file Outline drawing - 1.Outline drawing 型式承認第 Q 号 総紙数 枚の内 図名外観図 Three-dimensional outline drawing Three-dimensional outline drawing Cuff and components connection to be checked SYS DIA Hexahedral( six sides) drawing Blood pressure indicating method, dimension, identification(plate) to be checked SYS DIA Identification plate (example) Page10

12 Contents of application file Cuff and construction drawing- 2.Cuff drawing 型式承認第 Q 号 総紙数 図名 枚の内 カフ図 Description of dimension, internal air bag dimension, tube size Inflatable bladder 3.Construction drawing (assembly drawing) 型式承認第 Q 号総紙数枚の内 図名 構造図 Either disassembly or assembly drawing is acceptable. Pump, cuff, pressure sensor, deflation valve or connecting air related parts, circuit diagram for calculating plod pressure and display part to be checked. Page11

13 Contents of application file Display organization chart Identification plate - 4.Display mechanism chart Illustrate an example of the blood pressure display. Describe the dimension of the number on display. 型式承認第 Q 総紙数 図名 枚の内 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). 号 表示機構図 Systolic 135 mmhg Diastolic mmhg 5.Identification (plate) 型式承認第 Q 号 Describe the following items 総紙数枚の内 manufacturing business operator name 図名銘板図 Manufacturing year Manufacturing number type approval number (For instrument with electric power supply) Type of electric power supply and rated voltage (For instrument with digital display function) Measurement range and scale interval Page12

14 Contents of application file Test mode drawing, Block diagram, Circuit diagram, Flow chart, Detection organization chart 6.Test Mode 型式承認第 Q 号 How to switch into the test mode and conditions 7.Block Diagram Correlating chart from measuring to display blood pressure 8.Circuit diagram Correspond to blood diagram. Describe model number of CPU and detection part (pressure sensor) 9.Flow chart Flow chart of main routine from power-on to displaying blood pressure, and subroutine related to measuring blood pressure 10.Detecting mechanism chart Operating principle of detection part (pressure sensor), outline drawing, 総紙数枚の内図名受検モード図型式承認第 Q 号 総紙数図名 総紙数図名 枚の内ブロック図 型式承認第 Q 号 総紙数 枚の内 図名 回路図 型式承認第 Q 号 枚の内フローチャート 型式承認第 Q 号総紙数枚の内図名検出機構図 dimension and specification Page13

15 Contents of application file -Reference documents- Manufacturing process chart Manufacturing process before inspection Process symbols conform to JIS Z8206 Instruction for use Blood pressure measuring method and pressure sensor (transducer) type How to use Precaution 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

16 Adjustment of test instrument1 -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 software It is organized by program Method by circuit board It controls the valve releasing and closing by connecting lines Method by power supply It controls the valve releasing and closing by supplying power directly to the valve Method by closing pneumatic parts Blockconnecting 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

17 Adjustment of test instrument2 -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 automatically. 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 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

18 Adjustment of test instrument3 -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 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. Please identify the positive electrode of the code. + SYS DIA Page17

19 Other -Changes- Period for approval/disapproval Verification and inspection rules Article 71 Inspection periods 90 days in principle (6 months at longest) Changes after approval Change 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 representative Name and location of factory or workplace where said specified aneroid sphygmomanometer. Form Annex P23 Manufacturing business operator(import business operator) (Foreign manufacturing business operator) description change for approved type application (need one original) Type approval application Verification and inspection rules article 30 Application Verification 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. Some parts of test can be skipped. Application procedure same as new application Fees 142,000 Yen Refer to Article 4 Fees Page18

20 Other -Changes- Minor change notification Verification and inspection rules related to calibration by the specified 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 performance Note6 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. 型式承認第 Q 総紙数 枚の内 2-2 図名外観図 1 Renew Model Article 83 Valid period of approval in the Act Article 33 Renew approval in Verification and inspection rules 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. 号 Page19

21 Change procedure (Minor change application) Prior consultation NO Minor change notification is OK? type approval application flow (New type approval) Prepare the notification and necessary documents Receive YES Approved type amendment notification Construction and other related documents (2 copies) Company own inspection data Send the copy of application Send the receipt E N D This part is prepared by applicant Page20

22 For foreign manufacturing business operator, please refer to next page. 様式第 7 Form type 7 製造事業者 ( 輸入事業者 ) 型式承認申請書 Manufacturing business operator (Import business operator) type approval application 独立行政法人産業技術総合研究所殿 To The National Institute of Advanced Industrial Science and Technology (AIST) 年月日 Year / Month / Date 申請者住所 Applicant Name and address 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 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 We apply for approval of Article 79 No.1 in Measurement Act as follows. 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 ) *4 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 1.Business category 2. Name and location of factory or workplace of manufacturing the specified measuring instrument 3.Notification Year & Month & Date of Manufacturing operator 4. Specified measuring instrument 種類型式又は能力手数料 Category Model or Fees Performance 電気式 アネロイド型血 ( 電気式のみ ) 圧計計量範囲 Aneroid sphygmomanometer 目量 Electrical (Only electrical) Measurement range Scale Interval 円 Yen 備考 ( 型式の軽微な変更の場合はその旨 ) *1*3 輸入事業者 *2*4 輸入事業者は記載の必要なし Page21

23 This form is only for foreign manufacturing business operator, and attorney should be needed. 様式第 7 Form type 7 外国製造事業者型式承認申請書 Foreign manufacturing business operator type approval application 独立行政法人産業技術総合研究所殿 To The National Institute of Advanced Industrial Science and Technology (AIST) 年月日 Year / Month / Date 申請者住所 Applicant Name and address Company stamp 氏名 ( 名称及び代表者の氏名 ) 代理人住所 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 We apply for approval of Article 89 No.1 in Measurement Act as follows. 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 2. Name and location of factory or workplace of manufacturing 3 製造事業者の届出の年月日 *3 the specified measuring instrument 4 承認を受けようとする特定計量器 4. Specified measuring instrument 種類型式又は能力手数料 アネロイド型血 圧計 Aneroid sphygmomanometer 電気式 ( 電気式のみ ) 計量範囲 目量 Electrical (Only electrical) Measurement range Scale Interval 円 Yen 備考 ( 型式の軽微な変更の場合はその旨 ) *2*3 記載の必要なし Not necessary to write. Page22

24 届 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 Manufacturing business operator (Import business operator)(foreign manufacturing business operator) description change for approved type application 年月日 Year / Month / Date 独立行政法人産業技術総合研究所殿 To The National Institute of Advanced Industrial Science and Technology (AIST) 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 We apply for change as follows by Article 79 No.1 (pursuant to Article 81 No.4, 81 No4 and 79 No.1) in Measurement Act. 記 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 changes For example, change of company representative, address, or name of company. Describe old and new 2. Reasons of change For example, moving of headquarter 備考 ( 別紙としても可 ) 変更の発生した日 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

25 承認型式軽微変更届出書 Type approval minor change application 年月日 Year / Month / Date 独立行政法人産業技術総合研究所殿 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 Applicant Name and address Company stamp 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 We apply for the minor change of following approved specified measuring instrument by the verification and inspection conducted by ASIT based on Article 14 in Measurement Act. 1 Approved model (1) Approved model Type approval No. 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 (3) 型式又は能力電気式 (* 電気式のみ ) 2 変更を加えた事項 計量範囲 ~ mmhg 目量 1 mmhg 2 Details of change (2)Category Aneroid sphygmomanometer (3)Type or performance Electric Measure range ~mmhg Scale interval 1mmHg 3 変更箇所に係る図面 3 Drawings related to change 図名頁番号 Drawing title Page number 図面の変更又は 追加の別 Addition or change of drawing Page24

26 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 Manufacturing business operator (Import business operator) (Foreign business operator) type approval renewal application 年月日 Year / Month / Date 独立行政法人産業技術総合研究所殿 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 Applicant Name and adress Company stamp 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 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 ) 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 We apply the renewal of following approved specified measuring instrument by 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 specified measuring instrument 3. Notification Year & Month & Date of manufacturing operator 4. Specified measuring instrument to be applied 種類 Category アネロイド 型血圧計 Aneroid sphygmomanometer 型式承認 番 号 Type approval number 承認 ( 及び更新 ) の年月日 Approval Year Month Date 生産数 備 考 Remarks Number of instrument manufactured *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 Page25

27 Memo Page26

28 Contact Contact About Type Approval Aris Teles The National Institute of Advanced Industrial Science and Technology (AIST), National Metrology Institute of Japan(NMIJ) Application for Japanese Type Approval sphygmomanometers TEL FAX URL: AIST Central3, Umezono, About fees Tukuba, Ibaraki Japan Metrology Quality office TEL FAX Page27