Aneroid sphygmomanometer Alis Teles For Manufacturing business operator Import business operator Foreign manufacturing business operator National Metrology Institute of Japan 2013.4
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 p 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- 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
-Overview of verification i 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 t 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
-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 Ef Enforcement of fact article il 2Specified ifidmeasuring 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 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
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
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 p 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
Type approval application procedure ocedue (1/2) Application reception (Available by postal mail) Refer to the contact Metrology Institute (Dissemination Technology Division) To the person in charge of sphygmomanometers Appli ication Docu uments 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) 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 Ati Article 76in Measurement tact, Article Ati 30in Verification and inspection rules Refer to P8-14 Construction drawings and other relevant documents Continued to next page Page6
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: t 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
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 5.Identification(Plate) Three-dimensional outline drawing Hexahedral (6 sides) drawing 2.Cuff drawing 3.Assembly (disassembly) drawing 4.Display mechanism chart 6.Test mode drawing(*) 7.Block diagram(*) 8.Circuit diagram(*) 9.Flow chart(*) 10.Detection mechanism chart Manufacturing process Instruction Company own inspection result data (if available) *Only electric aneroid sphygmomanometer Page8
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 25-35mm 型式承認第 Q 号総紙数 枚の内 2 図名 5-10mm 5-10mm Page9
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
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
Contents of application file Display organization chart Identification plate - 4.Display mechanism chart 型式承認第 Q Illustrate an example of the blood pressure display. 総紙数 枚の内 Describe the dimension of the number on display. 図名 表示機構図 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 Systolic 135 mmhg 135 Diastolic 70 mmhg 5.Identification (plate) 型式承認第 Q 号 Describe the following items 総紙数枚の内 manufacturing f t i 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
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 総紙数枚の内 and conditions 図名受検モード図 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 型式承認第 Q 号 総紙数 枚の内 図名 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 総紙数図名 枚の内フローチャート 型式承認第 Q 号 Operating principle of detection part 総紙数 枚の内 (pressure sensor), outline drawing, 図名 検出機構図 dimension and specification Page13
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
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
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
Adjustment of test instrument3 -Taking Tki out of fit internal electrical ti lpower 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 if the positive i electrode of the code. + SYS DIA Page17
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 p 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
Other -Changes- 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 図名 Renew Model Article 83 Valid period of approval in the Act Article 33 Renew approval in Verification and inspection rules 号 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) Prior consultation NO Minor change notification is OK? type approval application flow (New type approval) YES Prepare the notification and necessary documents Receive 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
For foreign manufacturing business operator, please refer to next page. Form type 7 Manufacturing business operator (Import business operator) type approval application Year / Month / Date To The National Institute of Advanced Industrial Science and Technology (AIST) Applicant Name and address Company stamp We apply for approval of Article 79 No.1 in Measurement Act as follows. 2 1.Business category 3 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 Category Model or Fees Performance Aneroid Yen sphygmomanometer Electrical (Only electrical) Measurement range Scale Interval 輸入事業者 輸入事業者は記載の必要なし Page21
This form is only for foreign manufacturing business operator, and attorney should be needed. Form type 7 Foreign manufacturing business operator type approval application Year / Month / Date To The National Institute of Advanced Industrial Science and Technology (AIST) Applicant Name and address Company stamp Attoney Name and adress Company stamp We apply for approval of Article 89 No.1 in Measurement Act as follows. 2 3 2. Name and location of factory or workplace kl of manufacturing the specified measuring instrument 4. Specified measuring instrument Aneroid sphygmomanometer Electrical (Only electrical) Measurement range Scale Interval Yen 記載の必要なし Not necessary to write. Page22
Manufacturing business operator (Import business operator)(foreign manufacturing business operator) description change for approved type application Year / Month / Date To The National Institute of Advanced Industrial Science and Technology (AIST) Notification Applicant Name and address Company stamp WeapplyforchangeasfollowsbyArticle79No.1(pursuanttoArticle81No.4, 81 No4 and 79 No.1) in Measurement Act. 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 Remarks (Reference document) Change date Type approval list (All approved valid model) 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
Type approval minor change application Year / Month / Date To The National Institute of Advanced Industrial Science and Technology (AIST) Applicant Name and address Company stamp 16 38 14 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 Q mmhg 1 mmhg 2 Details of change (1) Approved model Type approval No. (2)Category Aneroid sphygmomanometer (3)Type or performance Electric Measure range ~mmhg Scale interval 1mmHg 3 Drawings related to change Drawing title Page number Addition or change of drawing Page24
Form type 10 10 Manufacturing business operator (Import business operator) (Foreign business operator) type approval renewal application Year / Month / Date To The National Institute of Advanced Industrial Science and Technology (AIST) Applicant Name and adress Company stamp 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 Category Type approval number Aneroid sphygmomanometer Remarks Approval Number of Year Month Date instrument manufactured 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
Memo Page26
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 TEL072-751-8667 FAX072-751-8693 e-mail nibp-ml@aist.go.jp URL: http://www.aist.go.jp http://www.nmij.jp 1-8-31 Midorigaoka, Ikeda, Osaka 563-8577 Japan About fees Metrology Quality office TEL072-751-8690 FAX072-751-8698751 Page27