18/30356489 DC : DRAFT APR 2018

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Current The latest, up-to-date edition.

BS EN 60601-1-10:2008 AMENDMENT 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS

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Published date: 03-06-2018

Publisher: British Standards Institution

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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
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER
  (PCLC) development
Annex A - General guidance and rationale
Annex C - Guide to marking and labelling requirements
          for ME EQUIPMENT and ME SYSTEMS

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BS EN 60601-1-10:2008 Amendment 2.

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Comment Closes On
Committee	CH/62/1
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Current

Standards Referencing This Book - (Show below) - (Hide below)

IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 14971:2007	Medical devices Application of risk management to medical devices

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