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IEC TR 62653:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Guideline for safe operation of medical equipment used for haemodialysis treatments
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

13-01-2022

Language(s)

English

Published date

12-06-2012

Publisher

International Electrotechnical Committee

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Treatment
6 Notification of INCIDENTS
7 Handling medical devices
Annex A (informative) - Explanatory technical remarks
Bibliography
Index of defined terms used in this guideline

IEC 62653:2012(E) which is a technical report, describes the technical requirements for use of equipment in haemodialysis, haemofiltration and haemodiafiltration. These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the haemodialysis treatment prescription. However, the organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. If applicable, the scope may be applicable to the use of the equipment in paediatrics, home haemodialysis, acute and sorbent dialysis systems. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.

Committee
TC 62/SC 62D
DevelopmentNote
Stability Date: 2018. (09/2017)
DocumentType
Technical Report
Pages
30
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy

Standards Relationship
NEN NPR IEC/TR 62653 : 2012 Identical

ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 60309-2:1999+AMD1:2005+AMD2:2012 CSV Plugs, socket-outlets and couplers for industrial purposes - Part 2: Dimensional interchangeability requirements for pin and contact-tube accessories

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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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