SC 62A

Common aspects of electrical equipment used in medical practice

 
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SC 62A Work programme (10)

Project

Reference

Document

Reference

Init.

Date

Current

Stage

Next

Stage

Working

Group

Project

Leader

Fcst. Publ.

Date

PNW TS 62A-1429 ED1

Safe, effective, and secure health software and health IT systems - Assurance cases
Application guidance — Guidance for the use of assurance cases – safety & security

62A/1429/NP PRVN
  • PRVN
  • Preparation of RVN

2021-02

2021-03

JWG 7 Stuart Harrison 2023-02
IEC 60601-1/AMD1/ISH1 ED3

Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

BPUB
  • BPUB
  • Being published

2020-08

PPUB
  • PPUB
  • Publication issued

2020-09

2021-03
IEC 62304 ED2

IEC 62304 Ed. 2: Health software - Software life cycle processes

62A/1422/CDV 2016-06 CCDV
  • CCDV
  • Draft circulated as CDV

2021-01

PRVC
  • PRVC
  • Preparation of RVC

2021-03

JWG 7 Patty Krantz-Zuppan 2022-02
IEC 63120 ED1

Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

62A/1424/CDV 2017-03 CCDV
  • CCDV
  • Draft circulated as CDV

2021-01

PRVC
  • PRVC
  • Preparation of RVC

2021-04

WG 20 Thomas Fischer 2022-02
IEC 80001-1 ED2

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

62A/1434/FDIS 2016-08 CFDIS
  • CFDIS
  • Draft circulated as FDIS

2021-02

PRVD
  • PRVD
  • Preparation of RVD

2021-03

JWG 7 Philip Raymond 2021-06
IEC TR 80001-2-2 ED2

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

62A/1437/RR 2021-02 ADTR
  • ADTR
  • Approved for DTR

2021-02

TDTR
  • TDTR
  • Translation of DTR

2022-10

JWG 7 Ben Kokx 2023-12
IEC TR 80001-2-8 ED2

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

62A/1436/RR 2021-02 ADTR
  • ADTR
  • Approved for DTR

2021-02

TDTR
  • TDTR
  • Translation of DTR

2022-10

JWG 7 Ben Kokx 2023-12
IEC 81001-5-1 ED1

Health Software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle

62A/1419/CDV 2018-09 PRVC
  • PRVC
  • Preparation of RVC

2021-02

2021-05

JWG 7 Georg Heidenreich 2021-11
ISO 81001-1 ED1

Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts

62A/1428/FDIS

2016-09 APUB
  • APUB
  • Approved for publication

2021-02

2021-02

JWG 7 Michelle Jump 2021-08
ISO TS 82304-2 ED1

Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice

62A/1343/NP 2019-11 ADTS
  • ADTS
  • Approved for DTS

2020-10

CDTS
  • CDTS
  • Draft circulated as DTS

2020-11

JWG 7 Charlie McCay 2022-02