I.S. EN 60601-1-10:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
08-04-2021
English
01-01-2008
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.
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
6 Accuracy of controls and instruments and protection against
hazardous outputs
7 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC)
development
Annex A (informative) - General guidance and rationale
Annex B (informative) - Description of dynamic performance of a PCLCS
Annex C (informative) - Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
Bibliography
Index of defined terms used with this collateral standard
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