CEI EN IEC 60601-2-16:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Hardcopy , PDF
English
01-11-2019
07-04-2025
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.
| Committee |
CT 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-5549-0
|
| Pages |
0
|
| ProductNote |
THIS STANDARD ALSO REFERS-JIS Z 2801 , CSN EN 14885 , AOAC 964 ,
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN IEC 60601-2-16:2019 | Identical |
| IEC 60601-2-16:2012 | Identical |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO 23500-1:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements |
| ISO 23500-2:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies |
| ISO 23500-3:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies |
| ISO 8637-1:2017 | Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ASTM E 1153 : 2014 | Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| ISO 15883-7:2016 | Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 23500-4:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies |
| ISO 23500-5:2019 | Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
| ISO 11197:2019 | Medical supply units |
Access your standards online with a subscription
-
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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.