IEC TR 62653:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Guideline for safe operation of medical equipment used for haemodialysis treatments
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
13-01-2022
English
12-06-2012
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Superseded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 |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.