Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda

“Invent a New India Using Knowledge”

“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru

“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS/ISO 8637 (2004): Cardiovascular Implants and ArtificialOrgans – Haemodialysers, Haemodiafilters, Haemofilters andHaemoconcentrators [MHD 6: Thoracic and CardiovascularSurgery Instruments]

IS/ISO 8637 : 2004(Superseding IS 13890 : 1994)

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ân;okfgdk vUrjksZi.k vkSj Ñf=ke vax —jÙkQ viksgd] jÙkQ fuL;and] jÙkQ MkbZfuL;and

,oa jÙkQ lkæad

Indian StandardCARDIOVASCULAR IMPLANTS AND ARTIFICIALORGANS — HAEMODIALYSERS, HAEMODIAFILTERS,

HAEMOFILTERS AND HAEMOCONCENTRATORS

ICS 11.040.40

© BIS 2012

B U R E A U O F I N D I A N S T A N D A R D SMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

April 2012 Price Group 8

Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHD 06

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 8637 : 2004 ‘Cardiovascular implants and artificialorgans — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators’ issued by theInternational Organization for Standardization (ISO) was adopted by the Bureau of Indian Standardson the recommendation of the Thoracic and Cardiovascular Surgery Instruments Sectional Committeeand approval of the Medical Equipment and Hospital Planning Division Council.

This standard is concerned with devices intended for haemodialysis, haemofilteration,haemodiafilteration and haemoconcentration in humans. The requirements specified in this IndianStandard will help to ensure their safety and satisfactory function.

It was not found practicable to specify materials of construction. This standard, therefore, requiresonly that materials have been tested and that the methods and results are made available uponrequest. There is no intention to specify, or to set limits on, the performance characteristics of thedevices because such restrictions are unnecessary for the qualified user and would limit thealternatives available when choosing a device for a specific application.

The dimensions of the blood ports and the dialysate of filtrate ports have been specified to ensurecompatibility of the device with the extracorporeal blood circuit specified in ISO 8638 : 2004‘Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers,haemodiafilters and haemofilters’. The design and dimensions have been selected in order to minimizethe risk of leakage of blood and the ingress of air.

This standard reflects the consensus of physicians, manufacturers and other interested parties fordevices that are approved for clinical use.

This standard was first published as IS 13890 : 1994 ‘haemodialysers, haemofilters andhaemoconcentrators — Specification’. This standard has been brought out it in alignment withInternational practices. After the publication of this standard, IS 13890 : 1994 shall be treated aswithdrawn.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard withoutdeviations. Certain conventions are, however, not identical to those used in Indian Standards. Attentionis particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should beread as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practiceis to use a point (.) as the decimal marker.

In this adopted standard, reference appears to certain International Standards for which IndianStandards also exist. The corresponding Indian Standards which are to be substituted in their respectiveplaces are listed below along with their degree of equivalence for the editions indicated:

International Standard Corresponding Indian Standard Degree of Equivalence

ISO 594-2 : 1991 Conical fittings with6% (Luer) taper for syringes, needlesand certain other medical equipment— Part 2: Lock fittings

IS 3234 (Part 2) : 1995 Conicalfittings with a 6% (Luer) taper forsyringes, needles and certain othermedical equipment: Part 2 Lockfittings (second revision)

Identical

(Continued on third cover)

Indian StandardCARDIOVASCULAR IMPLANTS AND ARTIFICIALORGANS — HAEMODIALYSERS, HAEMODIAFILTERS,

HAEMOFILTERS AND HAEMOCONCENTRATORS

IS/ISO 8637 : 2004

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The technical committee has reviewed the provisions of the following International Standards referredin this adopted standard and has decided that they are acceptable for use in conjunction with thisstandard:

International Standard Title

ISO 10993-4 : 2000 Biological evaluation of medical devices — Part 4: Selection of tests forinteractions with blood

ISO 10993-7 : 2008 Biological evaluation of medical devices — Part 7: Ethylene oxidesterilization residuals

ISO 10993-11 : 2006 Biological evaluation of medical devices — Part 11: Tests for systemictoxicity

For the purpose of deciding whether a particular requirement of this standard is complied with, thefinal value, observed or calculated expressing the result of a test or analysis, shall be rounded off inaccordance with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)’. The number ofsignificant places retained in the rounded off value should be the same as that of the specified valuein this standard.

International Standard Corresponding Indian Standard Degree of Equivalence

ISO 10993-1 : 1992 Biologicalevaluation of medical devices —Part 1: Evaluation and testing

ISO 8638 : 2004 Cardiovascularimplants and artificial organs —Extracorporeal blood circuit forhaemodialysers, haemodiafilters andhaemofilters

IS 12572 ( Part 1) : 1994 Biologicalevaluation of medical devices: Part 1Guidance on selection of tests (firstrevision)

IS/ISO 8638 : 2004 Cardiovascularimplants and artificial organs —Extracorporeal blood circuit forhaemodialysers, haemodiafilters andhaemofilters

Identical

do

(Continued from second cover)

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any formwithout the prior permission in writing of BIS. This does not preclude the free use, in course of imple-menting the standard, of necessary details, such as symbols and sizes, type or grade designations.Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are alsoreviewed periodically; a standard along with amendments is reaffirmed when such review indicates thatno changes are needed; if the review indicates that changes are needed, it is taken up for revision. Usersof Indian Standards should ascertain that they are in possession of the latest amendments or edition byreferring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Doc No. : MHD 06 (0119).

Amendments Issued Since Publication______________________________________________________________________________________

Amendment No. Date of Issue Text Affected______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

______________________________________________________________________________________

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