Aneroid sphygmomanometer
For
Manufacturing business operator
Import business operator
Foreign manufacturing business
operator
Alis
Teles
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
pp
file –How to p
prepare
p
2- ・・・・・・・・・・・・・・・・・・・・・・・・・・ 9
Contents of application file- Outline drawing- ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 10
Contents of application file ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 11
– Cuff and construction drawingContents 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 chartContents of application file ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 14
–Reference documentsAdjustment of test instrument –Test modeOther –Changes-
・・・・・・・・・・・・・・・・・・・・・・・・・・・
15 - 17
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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
Memo
Contact
・・・・・・・・・・・・・・・・・・・・・・・・・・
25
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
26
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
27
Page１
Introduction
-Overview
O
i off verification
ifi i andd type approvall 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
ifi d measuring
i instrument
i t
t usedd for
f business
b i
or certification
tifi ti classification
l ifi ti should
h ld
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,
verification following is the criteria for passing.
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
ype approval
pp ov number
u be ccan be indicated
d c ed oon approved
pp oved type
ype pproduct
oduc oof a notifying
o y g
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
p for the application.
pp
Note1: Marked as Designated manufacturing business operator or Designated foreign
manufacturing business operator.
Page２
Introduction
-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
pp
inspection.
p
Note 4: The manufacturing business operator of aneroid sphygmomanometer should notify the Minister of
Economy, Trade and Industry
Reference article
Act Article 2 “Definition”
E f
Enforcement
off Act
A article
i l 2 Specified
S ifi d measuring
i instruments
i
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
p
rules Non type
yp approval
pp
application
pp
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
T
Type
approvall system flow
fl chart
h
Sales Plan
Manufacturing
business operator?
YES
NO
Each prefecture
Notifying manufacturing
business operator
Already notify
manufacturing
business operator?
NO
Import business operator?
Or Foreign manufacturing
business operator?
NO
YES
YES
type approval
application
RETURN
Pass?
NO
YES
Approval
Manufacturing・
type approval marking
Disapproval
END
Page４
Type approval application flow
( New・Minor change application)
Prior Consultation
Inform the (tentative)
type approval number
Decide the model and
instrument for application
Prepare the
approval drawings
Manufacturing the
instrument and p
prepare
p
the
documents for application
Write the approval number in
drawings
Make 2 sets of drawings and
send
NO
Preliminary
review OK?
Approval
YES
Application accepted
Send the approval
notification
Pay fees
YES
Pass inspection?
NO
Disapproval
E N D
Approval notification
Send the approval drawings
Return the instrument inspected
Send the receipt
E N D
This part is prepared by applicant
Page５
Type
ype approval
app ova app
application
cat o pprocedure
ocedu e ((1/2)
/ )
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
Appliication Docu
uments
●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
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
h
with
i h non electric
l
i detection
d
i 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 in
Article
i Measurement
M
t Act,
A t Article
A ti l 30 in
i Verification
V ifi ti andd inspection
i
ti rules
l
Refer to P8-14 “Construction drawings and other relevant
Continued to next page
documents”
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
D t il
Detail
(N 5) instrument:
T t mode
Test
d (Note5)
i t
t 2
Normal mode instrument
(possible to measure the blood pressure):1
＊When any of submitted 3 instruments cannot be tested the automatic
zero settingg function, other instruments adjusted
j
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
d
to the
h instruments’
i
’ bodies
b di and
d functions.
f
i
Also,
Al
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
pp
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,
structure how to use,
use use condition and manufacturing process
(Verification and inspection rules article 30)
Submission documents and drawing title
Formal document ((2 copies)
p ) and reference document (1
( copy)
py)
＋
Formal documents
１．Outline drawing
Three-dimensional
outline drawing
Hexahedral (6 sides)
drawing
２．Cuff drawing
Reference documents
５．Identification(Plate)
６．Test mode drawing（＊）
７．Block diagram（＊）
８．Circuit diagram（＊）
Manufacturing process
Instruction
Company own inspection result data
(if available)
９．Flow chart（＊）
10．Detection mechanism chart
３．Assembly
(disassembly) drawing
４．Display mechanism chart
＊Only electric aneroid sphygmomanometer
Page８
Contents of application file
– How
H
to prepare 2 -
Drawing form
●Language: Japanese
●Size JIS PO138 A4 or A3
(A3 should be folded as A4 )
A4縦
●
●Left
side binding
g
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)
型式承認 第Ｑ
号
総紙数 ○○ 枚の内 ２
図名
5-10mm
25-35mm
2
50 70mm
50-70mm
5-10mm
Page９
Contents of application file
– Outline drawing １．Outline drawing
型式承認 第Ｑ
総紙数
図名
号
枚の内
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 drawing２．Cuff drawing
型式承認 第Ｑ
総紙数
図名
号
枚の内
カフ図
Description of dimension, internal air bag dimension, tube size
Inflatable bladder
３．Construction
３
Construction drawing
(assembly drawing)
型式承認 第Ｑ
総紙数
図名
号
枚の内
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
Display organization chart
Identification plate ４．Display mechanism chart
型式承認 第Ｑ
総紙数
号
枚の内
Illustrate an example
p of the blood pressure
p
display.
p y
図名
表示機構図
Describe 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).
Systolic
１３５
mmHg
Diastolic
７０
１３５
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 b
business
i
operator
t 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,
drawing Block diagram,
diagram Circuit
diagram, Flow chart, Detection organization chart
６．Test Mode
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
pressure
blood p
１０．Detecting mechanism
chart
Operating principle of detection part
(pressure sensor), outline drawing,
型式承認 第Ｑ
総紙数
図名
枚の内
受検モード図
型式承認 第Ｑ
総紙数
図名
号
枚の内
ブ
ブロック図
型式承認 第Ｑ
総紙数
図名
号
枚の内
回路図
型式承認 第Ｑ
総紙数
図名
号
枚の内
ﾌﾛｰﾁｬｰﾄ
型式承認 第Ｑ
総紙数
図名
号
号
枚の内
検出機構図
dimension and specification
Page13
Contents of application
pp
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
T t mode－
d
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
H to check
h k the
h automatic
i 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
Af
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
Non-invasive
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
T ki outt off internal
i t
l electrical
l t i l power code－
d
（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.
Pl
Please
id
identify
if the
h positive
i i electrode
l
d off the
h code.
d
＋
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)
Ch
Changes
after
f
approvall
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
g business operator(Import
p
( p
business operator)
p
)
Manufacturing
(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 off test can b
be skipped.
k
d
Application procedure same as new application
Fees 142,000 Yen Refer to Article 4 “Fees”
Page18
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 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.
型式承認 第Ｑ
Renew Model
号
総紙数 ○○ 枚の内 ２－２
図名
外観図１
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.
Page19
Change procedure
(Minor change application)
Prior consultation
NO
t
type
approvall
application flow
(New type approval)
Minor change
notification is OK?
YES
Prepare the notification
and necessary documents
Approved type
amendment notification
“Construction and other
related documents”(2
copies)
Receive
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.
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
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 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
２
３
４
事業の区分
＊2
1.Business category
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）
2. Name and location of factory or workplace of manufacturing
the specified measuring instrument
製造事業者の届出の年月日＊４
3.Notification Year & Month & Date of Manufacturing operator
承認を受けようとする特定計量器 4.
4 Specified measuring instrument
種
類
Category
型式又は能力
Model or
Performance
備
考
（型式の軽微な変更の場
合はその旨）
手数料
Fees
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
＊１＊３ 輸入事業者
＊２＊４ 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.
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
年
application
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
氏
所 Applicant Name and address Company stamp
名（名称及び代表者の氏名）
代理人
住
氏
所 Attoney Name and adress Company stamp
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
２
３
４
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
2 Name
2.
N
andd location
l
i off factory
f
or workplace
k l
off manufacturing
f
i
製造事業者の届出の年月日＊3
the specified measuring instrument
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
備
考
（型式の軽微な変更の場
合はその旨）
手数料
電気式
ア ネ ロ イ ド 型 血 （電気式のみ）
圧計
Aneroid 計量範囲
sphygmomanometer 目 量
円
Yen
Electrical (Only
electrical)
Measurement range
Scale Interval
＊２＊３記載の必要なし
Not necessary to write.
Page22
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
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
氏
所
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
備
考（別紙としても可）
1. Details of changes
For example, change of company
address, or name of company.
Describe old and new
representative,
2. Reasons of change
For example, moving of headquarter
Remarks (Reference document)
Change date
Type approval list (All approved valid
model)
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）
＊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
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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 承認を受けた型式 1 Approved model
（１）承認番号
型式承認第 Q
（２）種
類
（３）型式又は能力
号
アネロイド型血圧計
電気式（＊電気式のみ）
計量範囲
目
量
2 Details of change
３ 変更箇所に係る図面
3 Drawings related to change
名
Drawing title
(2)C t
(2)Category
Aneroid
A
id sphygmomanometer
h
t
∼
1 mmHg
２ 変更を加えた事項
図
(1) Approved model Type approval No.
頁 番 号
Page number
mmHg
(3)Type or performance
Electric
Measure range ～mmHg
Scale interval 1mmHg
図面の変更又は
追加の別
Addition or change of
drawing
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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
氏
所
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。
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
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
2. Name and location of factory or workplace of manufacturing the specified
measuring instrument
3. Notification Year & Month & Date of manufacturing operator
４ 承認を受けようとする特定計量器
種
類
Category
型式承認
承認（及び更新）
番
の 年
号
アネロイド
Type approval
型血圧計
number
Aneroid
sphygmomanometer
4. Specified measuring instrument to be applied
月 日
Approval
Y
Year
Month
M h
Date
生産数
備
Remarks
考
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
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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
e
mail nibp
[email protected]
[email protected]
URL： http://www.aist.go.jp
http://www.nmij.jp
1-8-31 Midorigaoka, Ikeda, Osaka
p
563-8577 Japan
About fees
Metrology Quality office
TEL072－751－8690
FAX072 751 8698
FAX072－751－8698
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