prEN IEC 62304:2021

Health software - Software life cycle processes

1.1 * Purpose This document defines the development and maintenance life cycle requirements for HEALTH SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for HEALTH SOFTWARE life cycle PROCESSES. 1.2 * Field of application This document applies to the development and maintenance of HEALTH SOFTWARE by a MANUFACTURER. MEDICAL DEVICE SOFTWARE is a subset of HEALTH SOFTWARE (see Figure 2). Therefore, this document applies to: - software as part of a MEDICAL DEVICE; - software as part of specific health hardware; - software as a MEDICAL DEVICE (SaMD); - software-only product for other health use. Figure 2 provides a graphical representation of the health software this document applies to. [Figure 2] NOTE 1 Examples of HEALTH SOFTWARE include the following: 1) software as a part of a MEDICAL DEVICE: software that is an integral part of a device such as an infusion pump or dialysis machine. 2) software as part of specific health hardware: patient wristband printer software, healthcare scanner software, health app on specific wearable hardware (i.e. watch, wristband, chestband). 3) software as a MEDICAL DEVICE (SaMD): software that is itself a MEDICAL DEVICE, such as a software application that performs diagnostic image analysis for making treatment decisions. A definition of software as a MEDICAL DEVICE is provided in [46] 1. 4) software-only product for other health use: hospital information systems, electronic health records, electronic medical records, mobile applications running on devices without physiologic sensors or detectors, software as a service, i.e. software executed in an external environment, providing calculation-results that fulfil the definition of a MEDICAL DEVICE. NOTE 2 This document can be used in the development and maintenance of HEALTH SOFTWARE. Before any type of software can be placed into service, activities are necessary before the software product is integrated into the SYSTEM. These SYSTEM activities are not covered by this document (see Figure 1), but can be found in related product standards (e.g., IEC 60601-1 [1] or IEC 82304-1 [15]). For software as a MEDICAL DEVICE (SaMD) additional guidance on ACTIVITIES at a system level (e.g. clinical EVALUATION) can be found in regulatory authority guidance documents. [...]

Gesundheits-Software - Software-Lebenszyklus-Prozesse

Logiciels de santé - Processus du cycle de vie du logiciel

Programska oprema v zdravstvu - Procesi v življenjskem ciklu programske opreme

General Information

• Status: Not Published
• Publication Date: 03-Sep-2019
• Withdrawal Date: 03-Mar-2020
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN IEC 62304:2021 - Health software - Software life cycle processes

Relations

• Revises: EN 62304:2006 - Medical device software - Software life-cycle processes
• Effective Date: 24-Jan-2023
• Revises: EN 62304:2006/A1:2015 - Medical device software - Software life-cycle processes
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 62304:2021
01-januar-2021
Programska oprema v zdravstvu - Procesi v življenjskem ciklu programske opreme
Health software - Software life cycle processes
Ta slovenski standard je istoveten z: prEN IEC 62304:2019
ICS:
13.020.60 Življenjski ciklusi izdelkov Product life-cycles
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN IEC 62304:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 62304:2021

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oSIST prEN IEC 62304:2021
62A/1349/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 62304 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2019-10-04 2019-12-27
SUPERSEDES DOCUMENTS:
62A/1310/CD,62A/1319A/CC

IEC SC 62A : COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
SECRETARIAT: SECRETARY:
United States of America Ms Hae Choe
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

TC 62,SC 62B,SC 62C,SC 62D,TC 65,TC 66,TC
76,TC 106,TC 108
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.

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

PROPOSED STABILITY DATE: 2024

NOTE FROM TC/SC OFFICERS:
Please note that IEC 62304 was circulated to IEC/SC 62A and ISO/TC 215 as a CDV/DIS in February,
2018. However, the document did not receive the approval to move forward. Therefore, the draft was
Copyright © 2019 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for
any other purpose without permission in writing from IEC.

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oSIST prEN IEC 62304:2021
62A/1349/CDV – 2 – IEC CDV 62304 © IEC 2019
revised, based on the comments received and other input, and was circulated as a 3rd Committee Draft
in January 2019. The document was also circulated for information/comment to ISO/TC 210.
The comments submitted on the 3rd Committee Draft were resolved by the IEC 62304 Project Team
(see 62A/1319A/CC).
The document is being circulated for ballot as a 2nd CDV/DIS in IEC/SC 62A and ISO/TC 215. The
document will also be circulated for information to ISO/TC 210.

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oSIST prEN IEC 62304:2021
IEC CDV 62304 © IEC 2019 – 3 – 62A/1349/CDV

NOTE DES RESPONSABLES DU TC/SC:
Please note that IEC 62304 was circulated to IEC/SC 62A and ISO/TC 215 as a CDV/DIS in February,
2018. However, the document did not receive the approval to move forward. Therefore, the draft was
revised, based on the comments received and other input, and was circulated as a 3rd Committee Draft
in January 2019. The document was also circulated for information/comment to ISO/TC 210.
The comments submitted on the 3rd Committee Draft were resolved by the IEC 62304 Project Team
(see 62A/1319A/CC).
The document is being circulated for ballot as a 2nd CDV/DIS in IEC/SC 62A and ISO/TC 215. The
document will also be circulated for information to ISO/TC 210.

---------------------- Page: 5 ----------------------
oSIST prEN IEC 62304:2021
62A/1349/CDV – 4 – IEC CDV 62304 © IEC 2019
1 CONTENTS
2
3 FOREWORD . 6
4 INTRODUCTION . 8
5 1 Scope . 11
6 1.1 * Purpose . 11
7 1.2 * Field of application .
...

SLOVENSKI STANDARD
oSIST prEN IEC 62304:2021
01-marec-2021
Programska oprema v zdravstvu - Procesi v življenjskem ciklu programske opreme
Health software - Software life cycle processes
Gesundheits-Software - Software-Lebenszyklus-Prozesse
Logiciels de santé - Processus du cycle de vie du logiciel
Ta slovenski standard je istoveten z: prEN IEC 62304:2021
ICS:
13.020.60 Življenjski ciklusi izdelkov Product life-cycles
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN IEC 62304:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 62304:2021

---------------------- Page: 2 ----------------------
oSIST prEN IEC 62304:2021
62A/1422/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 62304 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-01-01 2021-03-26
SUPERSEDES DOCUMENTS:
62A/1349/CDV, 62A/1383B/RVC

IEC SC 62A : COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
SECRETARIAT: SECRETARY:
United States of America Ms Hae Choe
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

TC 62,SC 62B,SC 62C,SC 62D,TC 65,TC 66,TC
76,TC 106,TC 108
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.

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

PROPOSED STABILITY DATE: 2024

Copyright © 2020 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it,
for any other purpose without permission in writing from IEC.

---------------------- Page: 3 ----------------------
oSIST prEN IEC 62304:2021
62A/1422/CDV – 2 – IEC CDV 62304 © IEC 2021

NOTE FROM TC/SC OFFICERS:
Please note that this draft is a joint project between IEC/SC 62A and ISO/TC 215 and is IEC led. During
the last CDV stage, this project was approved on the IEC side but not approved in ISO and CENELEC.
A task group was assigned to develop proposed resolutions to the comments and to the draft which
were reviewed by the 62304 Project Team and the IEC/ISO Joint Working Group. Attached is the result
of that extensive work. Some comments did not offer specific changes but provided ideas that may be
better utilized during the next maintenance cycle for this document.

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oSIST prEN IEC 62304:2021
IEC CDV 62304 © IEC 2021 – 3 – 62A/1422/CDV
1 CONTENTS
2
3 FOREWORD . 6
4 INTRODUCTION . 9
5 1 Scope . 11
6 1.1 * Purpose . 11
7 1.2 * Field of application . 11
8 1.3 Relationship to other standards . 12
9 2 * Normative references . 12
10 3 * Terms and definitions . 13
11 4 * General requirements . 21
12 4.1 * Quality management . 21
13 4.2 * RISK MANA
...