I.S. EN 60601-2-16:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
01-01-2015
13-06-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME
EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
208 General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical
electrical systems
210 Process requirements for the development of
PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT
and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT
Annexes
Annex G (normative) - Protection against HAZARDS of ignition
of flammable anaesthetic mixtures
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Examples of HAZARDS, foreseeable
sequences of events, and HAZARDOUS SITUATIONS
in HAEMODIALYSIS EQUIPMENT
Bibliography
Annex ZA (normative) - Normative references to international
publications with their corresponding
European publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EU Directives
Index of defined terms used in this particular standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.
| DevelopmentNote |
Supersedes I.S. HD 395-2-16. (09/2004) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
148
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN 60601-2-16 : 2016 | Identical |
| NF EN 60601-2-16 : 2015 | Identical |
| EN 60601-2-16:2015 | Identical |
| BS EN 60601-2-16:2015 | Identical |
| UNE-EN 60601-2-16:1999 | Identical |
| UNE-EN 60601-2-16:2015 | Equivalent |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : Users cannot be edited or removed once added to your Multi user PDF.