IEC TR 80001-2-2 : 1.0

Current

Current The latest, up-to-date edition.

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS

Publisher: International Electrotechnical Committee

Published:

Available Formats: PDF - English, Hardcopy - English
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Table of Contents - (Show below) - (Hide below)

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Use of SECURITY CAPABILITIES
5 SECURITY CAPABILITIES
6 Example of detailed specification under
  SECURITY CAPABILITY: Person authentication
  - PAUT
7 References
8 Other resources
9 Standards and frameworks
Annex A (informative) - Sample scenario showing the
        exchange of security information
Annex B (informative) - Examples of regional specification
        on a few SECURITY CAPABILITIES
Annex C (informative) - SECURITY CAPABILITY mapping to C-I-A-A
Bibliography

Abstract - (Show below) - (Hide below)

Describes an informative set of common, high-level securityrelated capabilities useful in understanding the user needs, the type of security controls to be considered and the RISKS that lead to the controls.

General Product Information - (Show below) - (Hide below)

Published
Document Type	Standard
Status	Current
Publisher	International Electrotechnical Committee
Pages
ISBN
Committee	TC 62

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
NEN NPR IEC/TR 80001-2-2 : 2012	Identical
AAMI IEC TIR 80001-2-2 : 2012	Identical
BS PD IEC TR 80001-2-2 : 2012	Identical
BS PD IEC TR 80001-2-2 : 2012	Identical
AAMI IEC TIR 80001-2-2 : 2012	Identical
NEN NPR IEC/TR 80001-2-2 : 2012	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

BS PD IEC TR 80001-2-3 : 2012	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
I.S. EN 82304-1:2017	HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
15/30246774 DC : 0	BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
BS PD IEC TR 80001-2-8 : 2016	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC TR 80001-2-2
BS EN 82304-1 : 2017	HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
BS PD IEC/TR 80001-2-9 : 2017	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-9: APPLICATION GUIDANCE - GUIDANCE FOR USE OF SECURITY ASSURANCE CASES TO DEMONSTRATE CONFIDENCE IN IEC TR 80001-2-2 SECURITY CAPABILITIES
AAMI IEC TIR 80001-2-1 : 2012	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
BS PD IEC TR 80001-2-1 : 2012	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP-BY-STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
EN 82304-1 : 2017	HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY (IEC 82304-1:2016)
AAMI IEC TIR 80001-2-7 : 2014	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL - APPLICATION GUIDANCE - PART 2-7: GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) ON HOW TO SELF-ASSESS THEIR CONFORMANCE WITH IEC 80001-1
NEMA HN 1 : 2013	MANUFACTURER DISCLOSURE STATEMENT FOR MEDICAL DEVICE SECURITY
ANSI C63.27 : 2017	EVALUATION OF WIRELESS COEXISTENCE
AAMI TIR57 : 2016	PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT
BS IEC 82304-1 : 2016	HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
AAMI IEC TIR 80001-2-8 : 2016	APPLICATION OF RISK MANAGEMENT FOR IT NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC 80001-2-2
AAMI IEC TIR 80001-2-3 : 2012	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
IEC TR 80001-2-9 : 1ED 2017	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-9: APPLICATION GUIDANCE - GUIDANCE FOR USE OF SECURITY ASSURANCE CASES TO DEMONSTRATE CONFIDENCE IN IEC TR 80001-2-2 SECURITY CAPABILITIES
IEC TR 80001-2-8 : 1ED 2016	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-8: APPLICATION GUIDANCE - GUIDANCE ON STANDARDS FOR ESTABLISHING THE SECURITY CAPABILITIES IDENTIFIED IN IEC TR 80001-2-2
BS PD ISO/TR 80001-2-7 : 2015	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - APPLICATION GUIDANCE - PART 2-7: GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) ON HOW TO SELF-ASSESS THEIR CONFORMANCE WITH IEC 80001-1
IEC TR 80001-2-3 : 1.0	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
IEC 82304-1 : 1ED 2016	HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
ISO TR 80001-2-7 : 2015	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - APPLICATION GUIDANCE - PART 2-7: GUIDANCE FOR HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) ON HOW TO SELF-ASSESS THEIR CONFORMANCE WITH IEC 80001-1
AAMI IEC TIR 80001-2-5 : 2014	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
IEC TR 80001-2-1 : 1.0	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP-BY-STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES
BS PD IEC TR 80001-2-5 : 2014	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
IEC TR 80001-2-5 : 1ED 2014	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS

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

ISO 13485 : 2016(R2020)	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
IEC 62304:2006+AMD1:2015 CSV	MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
IEC 60300-3-9 : 1.0	DEPENDABILITY MANAGEMENT - APPLICATION GUIDE - RISK ANALYSIS OF TECHNOLOGICAL SYSTEMS
IEEE 610.12 : 1990	GLOSSARY OF SOFTWARE ENGINEERING TERMINOLOGY
ISO TS 25238 : 2007(R2017)	HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH SOFTWARE
ISO 27799 : 2016	HEALTH INFORMATICS - INFORMATION SECURITY MANAGEMENT IN HEALTH USING ISO/IEC 27002
ISO 14971 : 2007(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO/IEC 27005 : 2011	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY RISK MANAGEMENT
ISO/IEC 15408-3 : 2008(R2014)	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - EVALUATION CRITERIA FOR IT SECURITY - PART 3: SECURITY ASSURANCE COMPONENTS
IEC 60601-1-6 :2013 (CON ED) 3.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
ISO/IEC 15408-2 : 2008(R2014)	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - EVALUATION CRITERIA FOR IT SECURITY - PART 2: SECURITY FUNCTIONAL COMPONENTS
ISO/IEC 20000-1 : 2011	INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 1: SERVICE MANAGEMENT SYSTEM REQUIREMENTS
IEC 61907 : 1.0	COMMUNICATION NETWORK DEPENDABILITY ENGINEERING
ISO/IEC 20000-2 : 2012	INFORMATION TECHNOLOGY - SERVICE MANAGEMENT - PART 2: GUIDANCE ON THE APPLICATION OF SERVICE MANAGEMENT SYSTEMS
ISO/IEC 27001 : 2013	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO TS 13606-4 : 2009	HEALTH INFORMATICS - ELECTRONIC HEALTH RECORD COMMUNICATION - PART 4: SECURITY
IEC 60601-1-8 : 2.1	MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
IEC 80001-1 : 1.0	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 1: ROLES, RESPONSIBILITIES AND ACTIVITIES
IEC TR 80001-2-3 : 1.0	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
ISO/IEC 27002 : 2013	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - CODE OF PRACTICE FOR INFORMATION SECURITY CONTROLS
ISO/IEC 15408-1 : 2009(R2015)	INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - EVALUATION CRITERIA FOR IT SECURITY - PART 1: INTRODUCTION AND GENERAL MODEL
ISO TR 27809 : 2007	HEALTH INFORMATICS - MEASURES FOR ENSURING PATIENT SAFETY OF HEALTH SOFTWARE
NEN 7510 : 2011	HEALTH INFORMATICS - INFORMATION SECURITY MANAGEMENT IN HEALTHCARE
IEC TR 80001-2-1 : 1.0	APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP-BY-STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES

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IEC TR 80001-2-2 : 1.0

Table of Contents - (Show below) - (Hide below)

Abstract - (Show below) - (Hide below)

General Product Information - (Show below) - (Hide below)

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Standards Referenced By This Book - (Show below) - (Hide below)

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

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