ISO/DIS 8600-8

Endoscopes -- Medical endoscopes and endotherapy devices

Endoscopes -- Endoscopes médicaux et dispositifs d'endothérapie

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 8600-8
ISO/TC 172/SC 5 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-11-16 2021-02-08
Endoscopes — Medical endoscopes and endotherapy
devices —
Part 8:
Particular requirements for capsule endoscopes
ICS: 37.020; 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
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STANDARDS MAY ON OCCASION HAVE TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 8600-8:2020(E)
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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ISO/DIS 8600-8:2020(E)
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ii © ISO 2020 – All rights reserved
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ISO/DIS 8600-8:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Requirements specific for capsule endoscopes_ ........................................................................................................ 2

4.2.1 Maximum diameter ....................................................................................................................................................... 2

4.2.2 Maximum length .............................................................................................................................................................. 2

4.2.3 EMC/EMI ................................................................................................................................................................................ 2

5 Testing ............................................................................................................................................................................................................................. 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Testing specific for capsule endoscopes ........................................................................................................................... 2

5.2.1 Maximum diameter ....................................................................................................................................................... 2

5.2.2 Maximum length .............................................................................................................................................................. 2

6 Marking .......................................................................................................................................................................................................................... 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Minimum marking specific for capsule endoscopes .............................................................................................. 3

7 Instruction manual ............................................................................................................................................................................................ 3

7.1 General ........................................................................................................................................................................................................... 3

7.2 Information specific for capsule endoscopes ............................................................................................................... 3

8 Packaging ..................................................................................................................................................................................................................... 4

Bibliography ................................................................................................................................................................................................................................ 5

© ISO 2020 – All rights reserved iii
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ISO/DIS 8600-8:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

...