ISO/DTS 5137

Medical device maintenance management programme for healthcare delivery organizations (HDO)

This document provides guidance on the maintenance management of medical devices that are under the supervision of healthcare delivery organizations. This document is not applicable to: a) modification, refurbishment or remanufacturing of medical devices; b) manufacturers that are responsible for installation, testing, maintenance, and servicing on medical devices that they have placed on the market; or c) implantable or single-use medical devices.

Programme de gestion de la maintenance des dispositifs médicaux pour les organismes de prestations de soins de santé (HDO)

General Information

• Status: Not Published
• ICS: 11.020.01 - Quality and environmental management in health care
• Technical Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 05-Nov-2025
• Completion Date: 05-Nov-2025

Overview

ISO/DTS 5137:2025, titled Medical Device Maintenance Management Programme for Healthcare Delivery Organizations (HDOs), provides comprehensive guidance on the maintenance management of reusable medical devices within healthcare settings. Developed by ISO Technical Committee ISO/TC 210/WG 7 and published in 2025, this document focuses on ensuring safe, effective, and compliant maintenance processes managed by healthcare organizations rather than manufacturers.

The guideline excludes modification, refurbishment, remanufacturing, and maintenance performed by manufacturers or those responsible for implantable or single-use devices. Instead, it is tailored for healthcare delivery organizations and their biomedical engineering services (BES) to help maintain medical devices throughout their lifecycle, from commissioning to decommissioning.

Key Topics

• Maintenance Management Programme
  This section outlines the establishment of a structured maintenance programme that addresses the technical and administrative requirements to keep medical devices operational according to manufacturer specifications.

• Roles and Responsibilities
  Emphasizes the importance of defined responsibility and authority within healthcare delivery organizations, including the role of biomedical engineering services representatives.

• Resource and Infrastructure Management
  Guidance on ensuring adequate resources such as trained personnel, infrastructure, and contamination control to support maintenance activities effectively.

• Maintenance Process Execution
  Detailed insight into planning, testing, commissioning, servicing, storage, decommissioning, and disposal of medical devices within healthcare facilities, including handling of spare parts.

• Performance Measurement and Improvement
  Includes techniques for maintenance process measurement, data analysis, incident handling, nonconformance control, audits, and continuous improvement plans.

• Regulatory and Quality System Integration
  Aligns with ISO 13485 and ISO 9001 standards to facilitate healthcare organizations’ compliance with medical device maintenance regulatory requirements.

• Terminology and Definitions
  Clarifies critical terms such as authorized representative, biomedical engineering services, calibration, maintenance, risk, and preventive maintenance among others.

Applications

• Healthcare Delivery Organizations (HDOs)
  Hospitals, clinics, and health centers adopting effective maintenance management programmes to ensure the reliability and safety of reusable medical devices.

• Biomedical Engineering Services (BES)
  Both in-house and third-party biomedical engineering teams responsible for maintaining medical equipment, ensuring compliance with international standards.

• Maintenance Service Providers
  External maintenance suppliers can implement ISO/DTS 5137 guidelines within their quality management systems to offer standardized services to HDOs.

• Quality and Compliance Management
  Organizations seeking certification or alignment with ISO 13485 or ISO 9001 can integrate the standard’s frameworks to enhance medical device maintenance controls and audit readiness.

• Risk and Safety Management
  Healthcare organizations aiming to reduce device downtime and incidents related to medical devices can apply the standard’s risk management and adverse event reporting recommendations.

Related Standards

• ISO 13485
  Specifies quality management systems requirements for medical device manufacturers and provides a foundation for maintenance quality assurance in healthcare settings.

• ISO 9001
  General quality management standard that can be integrated with DTS 5137 requirements for holistic organizational quality practices.

• IEC 62353
  Relates to the maintenance and testing of medical electrical equipment, complementing ISO/DTS 5137 maintenance activities.

• ISO 81001-1
  Addresses healthcare IT safety and management, overlapping with device maintenance in digital health technologies.

• ISO/IEC Guide 63
  Offers guidance on managing risks associated with medical devices, critical in maintenance programme risk assessments.

By implementing the ISO/DTS 5137 standard, healthcare delivery organizations can significantly enhance the operational lifecycle of medical devices, ensuring safety, compliance, and quality patient care. This standard empowers HDOs to establish robust maintenance programmes tailored to their specific operational context and regulatory environment.

Standards Content (Sample)

FINAL DRAFT
Technical
Specification
ISO/TC 210
Medical device maintenance
Secretariat: ANSI
management programme for
Voting begins on:
healthcare delivery organizations
2025-11-05
(HDO)
Voting terminates on:
2025-12-31
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
Technical
Specification
ISO/TC 210
Medical device maintenance
Secretariat: ANSI
management programme
Voting begins on:
for healthcare delivery
organizations (HDO)
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Maintenance management programme . 3
4.1 General requirements .3
4.2 Outsourced activities . .4
4.3 Documentation requirements .4
4.3.1 General .4
4.3.2 Control of documents .5
4.3.3 Control of records .5
4.3.4 Maintenance management information system (MMIS) .5
4.3.5 Technical library .6
5 Management responsibility . 6
5.1 Planning .6
5.1.1 Quality objectives .6
5.1.2 Maintenance management programme planning .6
5.2 Responsibility and authority .6
5.3 Biomedical, clinical engineering services representative .7
6 Resource management . 7
6.1 Provisions of resources .7
6.2 Human resources .7
6.3 User training .8
6.4 Infrastructure .8
6.5 Contamination control .8
7 Maintenance programme realization . 8
7.1 Planning of maintenance service realization .8
7.1.1 General .8
7.1.2 Maintenance intervals .9
7.1.3 Risk management .9
7.1.4 Release for service .9
7.2 Testing, commissioning and acceptance of new reusable medical devices .10
7.2.1 Testing and commissioning and acceptance .10
7.3 Maintenance services .10
7.3.1 General .10
7.3.2 Identification .10
7.4 Maintenance .10
7.4.1 User maintenance .10
7.4.2 Preventive maintenance .11
7.4.3 Routine inspection . 12
7.4.4 Unscheduled maintenance or repair . 12
7.4.5 Predictive maintenance . 13
7.5 Storage . 13
7.6 Decommissioning and disposal of medical devices . 13
7.7 Spare parts .14
8 Measurement, analysis, and improvement . 14
8.1 Measurement of maintenance processes .14
8.2 Data analysis .14
8.3 Control of nonconforming medical devices .14
8.3.1 General .14
8.3.2 Actions in response to nonconforming product .14

iii
8.4 Adverse effects and incident investigation and reporting . 15
8.5 Alert, safety, field corrective action and recall notices . 15
8.6 Internal audit . 15
8.7 Medical device replacement plan .16
8.8 Advisory services .16
Bibliography . 17

iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
Introduction
This document specifies requirements for use by healthcare delivery organizations (HDO) for a maintenance
management programme of reusable medical devices that require maintenance, including testing and
commissioning, servicing and final decommissioning and disposal of medical devices, or provision of
associated activities (e.g. technical support). The requirements in this document can also be used by
suppliers or other external parties providing maintenance services to such organizations.
Due to different local, national or regional requirements this document can only act as top-level document
providing requirements for the maintenance of medical devices in HDOs. The requirements in this document
are only a framework for the maintenance and general guidance. The HDO or maintenance provider should
establish and maintain an effective maintenance programme for medical devices.
The applicable regulatory requirements differ from nation to nation and region to region. The organization
should understand how the requirements in this document can be implemented in light of regulatory
requirements in the respective jurisdictions in which the medical device is serviced and maintained.
It is not the intent of this document to imply the need for uniformity in the structure of different maintenance
management programmes, uniformity of documentation or alignment of documentation to the clause
structure of this document.
This document follows the structure of ISO 13485. Therefore, if a maintenance service provider in an HDO or
subcontracted by the HDO holds a certification according to ISO 13485 or ISO 9001 or aims to be certified to
aforementioned standards the provider can implement the requirements of this document into the quality
management system.
vi
FINAL DRAFT Technical Specification ISO/DTS 5137:2025(en)
Medical device maintenance management programme for
healthcare delivery organizations (HDO)
1 Scope
This document specifies requirements for the maintenance management programme of reusable medical
devices that require maintenance under the supervision of healthcare delivery organizations (HDOs). This
document neither provides guidance nor is applicable to modification of medical device. This document does
not apply to manufacturers that install, test, maintain, and service their own medical device.
This document focuses on HDOs and biomedical engineering services (BES) responsibilities.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
authorized representative
AR
natural or legal person established within a specific territory who has received and accepted a written
mandate from a manufacturer, located outside this specific territory, to act on the manufacturer’s behalf for
specified tasks related to manufacturer’s obligations under local regulatory requirements
3.2
biomedical, clinical engineering services representative
person representing biomedical engineering services (BES) (3.3)
3.3
biomedical engineering service
BES
in-house or third-party organization responsible and authorized for carrying out, implementing or managing
medical device (3.10) maintenance (3.9) activities
3.4
calibration
operation that establishes, under specified conditions, in a first stage, a relationship between values and
uncertainties of measurement provided by standards and corresponding indications with associated
uncertainties
Note 1 to entry: Adapted from Reference [10].

3.5
competence
documented requirement for an individual to properly perform a specific job, encompassing a combination
of knowledge, skills and behaviour
3.6
downtime
percentage of time that a device is out of service
Note 1 to entry: Adapted from Reference [11].
3.7
healthcare delivery organization
HDO
facility or enterprise such as a clinic or hospital that provides healthcare services
[SOURCE: ISO 81001-1:2021, 3.1.4]
3.8
incident
adverse event involving a medical device (3.10) that results in, or could result in, harm to a person, including
device malfunction, performance deterioration, use error, inadequate information, or undesirable side effects
3.9
maintenance
combination of all technical and administrative means, including supervisory ones, to keep medical device
(3.10) and systems in a normal working condition, or restored to normal working condition
[SOURCE: IEC 62353:2014, 3.21]
3.10
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material
or other similar or related article, intended by the manufacturer to be used, alone or in combination, for
human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in
or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal or human tissues, or both;
— devices for in vitro fertilization or assisted reproduction technologies.

[SOURCE: ISO 13485:2016, 3.11]
3.11
medical device supplier
manufacturer, authorized representative (AR) (3.1), distributor or medical device (3.10) registration holder
3.12
method statement
document in which the biomedical engineering services (BES) (3.3) translates the demands of maintenance
(3.9) into a delivery plan with resources, allocations and methodologies
[SOURCE: ISO 41011:2024, 3.4.7, modified — “service provider” was changed to “biomedical engineering
service”; “demands set out in the specification and service level agreement” was changed to “demands of
maintenance”.]
3.13
nonconforming medical device
medical device (3.10) that does not function as intended
3.14
preventive maintenance
planned maintenance (3.9) programme which specifies intervals, tasks and activities to be done to ensure
that all medical devices (3.10) are operating as per manufacturer’s specifications and are in safe working
condition
3.15
predictive maintenance
use of data-driven, proactive maintenance (3.9) methods to analyse equipment condition and predict when
maintenance should be performed
3.16
verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
[SOURCE: ISO/IEC Guide 63:2019, 3.19]
3.17
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO/IEC Guide 63:2019, 3.10, modified — Note 1 to entry was removed.]
3.18
risk management
systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring risk (3.17)
[SOURCE: ISO/IEC Guide 63:2019, 3.15]
4 Maintenance management programme
4.1 General requirements
4.1.1 The HDO shall document a maintenance management programme and maintain its effectiveness in
accordance with the requirements of this document. Regulatory requirements can apply.
The HDO shall establish, implement, and maintain any requirement, procedure, activity, or arrangement
required to be documented by this document. Regulatory requirements can apply.

The maintenance management programme shall ensure:
a) the medical device performs as intended;
b) the medical device is safe for patients, users, and others.
Maintenance, which consists of scheduled and unscheduled maintenance, shall be based on instructions
for use and maintenance manuals as provided by the manufacturer and good engineering practice. In
the absence of information from the manufacturer, applicable safety standards and clinical performance
requirements shall be used.
4.1.2 For each maintenance management process, the HDO shall:
a) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective;
b) ensure the availability of resources and information necessary to support the operation and monitoring
of these processes;
c) implement actions necessary to achieve planned results and maintain the effectiveness of these
processes;
d) monitor, measure as appropriate, and analyse these processes;
e) establish and maintain records needed to demonstrate conformance to this document and compliance
with applicable regulatory requirements.
4.1.3 The maintenance management programme may include:
a) training of personnel responsible for maintenance activities;
b) initial inspections, preventive maintenance, safety evaluations and verification of medical devices and
accessories;
c) a responsive repair service that minimizes medical device downtime;
d) quality assurance programme for continuous improvement;
e) standardization of maintenance activities;
f) assistance in training medical personnel on safe and effective operation of medical devices.
4.2 Outsourced activities
When the HDO chooses to outsource any process that affects maintenance activities, it shall monitor and
ensure control over such processes. The HDO shall retain responsibility of conformity to this document and
compliance with applicable regulatory requirements for outsourced processes.
4.3 Documentation requirements
4.3.1 General
The maintenance management programme documentation shall include:
a) documented quality objectives (see 5.1.1);
b) documented procedures and records required by this document;
c) documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation, and control of its processes;
d) other documentation;
NOTE Applicable regulatory requirement can require specific documentation.
e) risk registry/assessments;
f) method statements.
4.3.2 Control of documents
Records are a special type of document and shall be controlled according to the requirements given in 4.3.3.
A documented procedure shall define the controls needed to:
a) review and approve documents for adequacy prior to issue;
b) review, update as necessary and re-approve documents;
c) ensure that the current revision status of and changes to documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin, determined by the organization to be necessary for the
planning and operation of the maintenance management system, are identified and their distribution
controlled;
g) prevent deterioration or loss of documents;
h) prevent the unintended use of obsolete documents and apply suitable identification to them.
The HDO shall ensure that changes to documents are reviewed and approved either by the original approving
function or another designated function that has access to pertinent background information upon which to
base its decisions.
The HDO shall define
...

ISO/TSDTS 5137:2025(E)
ISO/TC 210/WG 7
Secretariat: ANSI
Date: 2024-06-032025-10-22
Medical device maintenance management programme for
healthcare delivery organizations (HDO)

ISO/TS 5137:2025(E)
DTS stage
Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change
without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of

© ISO/TS 5137 – All rights reserved

© ISO 5137 – 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of
this publication may be reproduced or utilized otherwise in any form or by any means, electronic or
mechanical, including photocopying, or posting on the internet or an intranet, without prior written
permission. Permission can be requested from either ISO at the address below or ISO’s member body in the
country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
iii
© ISO/TS 5137– All rights reserved

ISO/TS 5137:2025(E)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission
can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: copyright@iso org
© ISO/TS 5137 – All rights reserved

Published in Switzerland
v
Contents
Foreword . vii
Introduction . viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Maintenance management programme . 5
4.1 General requirements . 5
4.2 Outsourced activities . 6
4.3 Documentation requirements . 6
5 Management responsibility . 8
5.1 Planning . 8
5.2 Responsibility and authority . 8
5.3 Biomedical, clinical engineering services representative . 9
6 Resource management . 9
6.1 Provisions of resources . 9
6.2 Human resources . 9
6.3 User training . 10
6.4 Infrastructure . 10
6.5 Contamination control . 10
7 Maintenance programme realization . 11
7.1 Planning of maintenance service realization . 11
7.2 Testing, commissioning and acceptance of new reusable medical devices . 12
7.3 Maintenance services . 13
7.4 Maintenance . 13
7.5 Storage . 16
7.6 Decommissioning and disposal of medical devices . 16
7.7 Spare parts . 17
8 Measurement, analysis, and improvement . 17
8.1 Measurement of maintenance processes . 17
8.2 Data analysis . 17
8.3 Control of nonconforming medical devices . 18
8.4 Adverse effects and incident investigation and reporting . 18
8.5 Alert, safety, field corrective action and recall notices . 18
8.6 Internal audit . 19
8.7 Medical device replacement plan . 19
8.8 Advisory services . 20
Bibliography . 21

vi
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is
normally carried out through ISO technical committees. Each member body interested in a subject
for which a technical committee has been established has the right to be represented on that
committee. International organizations, governmental and non-governmental, in liaison with ISO,
also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed
for the different types of ISO documents should be noted. This document was drafted in
accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation
of this document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning
the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date
of publication of this document, ISO had not received notice of (a) patent(s) which may be
required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent
rights. Details of any patent rights identified during the development of the document will be in
the Introduction and/or on the ISO list of patent declarations received (see ).
Any trade name used in this document is information given for the convenience of users and does
not constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO'sISO’s adherence
to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for products with a health purpose including medical devices.
Any feedback or questions on this document should be directed to the user’s national standards
body. A complete listing of these bodies can be found at www.iso.org/members.html.
vii
Introduction
This document specifies requirements for use by Healthcare Delivery Organizationshealthcare
delivery organizations (HDO) for a maintenance management programme of reusable medical
devices that require maintenance, including testing and commissioning, servicing and final
decommissioning and disposal of medical devices, or provision of associated activities (e.g.
technical support). The requirements in this document can also be used by suppliers or other
external parties providing maintenance services to such organizations.
Due to different local, national or regional requirements this document can only act as top-level
document providing requirements for the maintenance of medical devices in healthcare
delivering organizations.HDOs. The requirements in this document are justonly a framework for
the maintenance and general guidance. The healthcare delivering organizationThe HDO or
maintenance provider should establish and maintain an effective maintenance programme for
medical devices.
The applicable regulatory requirements differ from nation to nation and region to region. The
organization needs toshould understand how the requirements in this document can be
implemented in light of regulatory requirements in the respective jurisdictions in which the
medical device is serviced and maintained.
It is not the intent of this document to imply the need for uniformity in the structure of different
maintenance management programmes, uniformity of documentation or alignment of
documentation to the clause structure of this document.
This document is structured followingfollows the structure of ISO 13485. Therefore, if a
maintenance service provider in a healthcare delivering organizationan HDO or subcontracted by
the healthcare delivering organizationHDO holds a certification according to ISO 13485 or
ISO 9001 or aims to be certified to aforementioned standards the provider can implement the
requirements of this document into the quality management system.
viii
ISO/TS 5137:2025(E)
— .
ix
© ISO/TS 5137 – All rights reserved

Medical device maintenance management programme for
healthcare delivery organizations (HDO)

21 1 Scope
This document specifies requirements for the maintenance management programme of reusable
medical devices that require maintenance under the supervision of healthcare delivery
organizations. (HDOs). This document neither provides any guidance nor is applicable to
modification of medical device. This document does not apply to manufacturers that install, test,
maintain, and service their own medical device.
This document focuses on healthcare delivery organizations (HDO)HDOs and biomedical
engineering services (BES) responsibilities.
32 Normative references
There are no normative references in this document.
43 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at
https://www.iso.org/obphttps://www.iso.org/obp
— — IEC Electropedia: available at
https://www.electropedia.org/https://www.electropedia.org/
4.13.1 3.1
authorized representative
(AR)
any natural or legal person established within a specific territory who has received and accepted
a written mandate from a manufacturer, located outside this specific territory, to act on the
manufacturer'smanufacturer’s behalf for specified tasks related to manufacturer’s obligations
under local regulatory requirements
4.2.0.0.0 3.2
3.2 Biomedical,Clinical Engineering Services
biomedical, clinical engineering services representative
person representing biomedical engineering services (BES) (3.3 representative for Biomedical
Engineering Services
4.2.1.1.1 3.3
Biomedical Engineering Service
(BES)
Any )
3.3
biomedical engineering service
BES
in-house or third-party personnel, organization, responsible to carryand authorized for carrying
out, implementimplementing or managemanaging medical device (3.10) maintenance (3.9)
activities within the scope of this document
4.33.4 3.4
calibration
operation that establishes, under specified conditions, in a first stage, a relationship between
values and uncertainties of measurement provided by standards and corresponding indications
with associated uncertainties”
“Note 1 to entry: Adapted from Reference [10[VIM, 2012]”].
4.43.5 3.5
competence
Documenteddocumented requirement for an individual to properly perform a specific job which
encompasses, encompassing a combination of knowledge, skills and behaviour
4.53.6 3.6
downtime
Percentagepercentage of time that a device is out of service [
Note 1 to entry: Adapted from Reference [11[World Health Organization]].
4.6.0.0.0 3.7
harm
injury or damage to the health of people, or damage to property or the
environment [SOURCE: ISO/IEC Guide 63:2019, 3.1]
4.93.7 3.8
healthcare delivery organization
(HDO)
facility or enterprise such as a clinic or hospital that provides healthcare services [Source
[SOURCE: ISO 81001-1:2021, 3.1.4]
4.103.8 3.9
incident
An adverse event involving a medical device (3.10) that results in, or could result in, harm to a
person, including device malfunction, performance deterioration, use error, inadequate
information, or undesirable side effects.
4.113.9 3.10
maintenance
combination of all technical and administrative means, including supervisory ones, to keep
medical device (3.10) and systems in a normal working condition, or restored to normal working
condition
[SOURCE: IEC 62353:2014, 3.21]
4.123.10 3.11
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:

— — diagnosis, prevention, monitoring, treatment or alleviation of disease;
— — diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— — investigation, replacement, modification, or support of the anatomy or of a physiological
process;
— — supporting or sustaining life;
— — control of conception;
— — disinfection of medical devices;
— — providing information by means of in vitro examination of specimens derived from the
human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in
others include: — disinfection substances; — aids for persons with disabilities; — devices incorporating
animal or human tissues, or both; — devices for in vitro fertilization or assisted reproduction technologies.
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal or human tissues, or both;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE:GHTF/SG1/N071:2012, 5.1] ISO 13485:2016, 3.1211]
4.133.11
medical device supplier
manufacturer, authorized representative (AR) (3.1),), distributor or medical device (3.10)
registration holder
4.143.12
4.14.1.1.1 3.13
method statement
document in which the biomedical engineering serviceservices (BES) (3.3) translates the demands
of maintenance (3.9) into a delivery plan with resources, allocations and methodologies
[SOURCE: ISO 41011:2024, 3.4.7, modified — “service provider” was changed to “biomedical
engineering service”; “demands set out in the specification and service level agreement” was
changed to “demands of maintenance”.]
4.153.13
3.14
nonconforming medical device
medical device (3.10) that does not function as intended
4.163.14 3.15
preventive maintenance
planned maintenance (3.9) programme which specifies intervals, tasks and activities to be done
to ensure that all medical devices (3.10) are operating as per manufacturer’s specifications and are
in safe working condition
4.173.15
3.16
predictive maintenance
the use of data-driven, proactive maintenance (3.9) methods to analyzeanalyse equipment
condition and predict when maintenance should be performed.
4.193.16 3.17
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled. [Source: IEC 60601-1:2005/Amd 1:2012, definition 3.138]
3.18[SOURCE: ISO/IEC Guide 63:2019, 3.19]
4.203.17
risk
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO/IECGuide IEC Guide 63:2019, 3.10], modified — Note 1 to entry was removed.]
4.213.18 3.19
risk management
systematic application of management policies, procedures and practices to the tasks of
analyzinganalysing, evaluating, controlling and monitoring risk (3.17)
[SOURCE: ISO/IEC Guide 63:2019, 3.15]

6.0.0.0.0 3.20
severity
measure of the possible
consequences of a hazard
[SOURCE: ISO/IEC Guide
63:2019, 3.17]
10.0.0.0.0 3.21
uptime
amount or percentage of time a medical device is available for use

144 Maintenance management programme
14.14.1 General requirements
14.1.14.1.1 The HDO shall document a maintenance management programme and maintain its
effectiveness in accordance with regulatory requirements, and the requirements of this
specificationdocument. Regulatory requirements can apply.
The (HDO) shall establish, implement, and maintain any requirement, procedure, activity, or
arrangement required to be documented by this document or applicable regulatory. Regulatory
requirements can apply.requirements.
The maintenance management programme shall ensure:
a) the medical device performs as intended;
b) the medical device is safe for patients, users, and others.
Maintenance, which consists of scheduled and unscheduled maintenance, shall be based on
instructions for use and maintenance manuals as provided by the manufacturer and good
engineering practice. In the absence of information from the manufacturer, applicable safety
standards and clinical performance requirements shall be used.
14.1.24.1.2 For each maintenance management process, the HDO shall:
a) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective;
b) ensure the availability of resources and information necessary to support the operation and
monitoring of these processes;
c) implement actions necessary to achieve planned results and maintain the effectiveness of
these processes;
d) monitor, measure as appropriate, and analyse these processes;
e) establish and maintain records needed to demonstrate conformance to this document and
compliance with applicable regulatory requirements.
14.1.34.1.3 The maintenance management programme may include:
a) training of personnel responsible for maintenance activities,;
b) initial inspections, preventive maintenance, safety evaluations and verification of medical
devices and accessories,;
c) a responsive repair service that minimizes medical device downtime,;
d) quality assurance programme for continuous improvement,;
e) standardization of maintenance activities,;
f) assistance in training medical personnel on safe and effective operation of medical devices.
14.24.2 Outsourced activities
When the HDO chooses to outsource any process that affects maintenance activities, it shall
monitor and ensure control over such processes. The HDO shall retain responsibility of
conformity to this document and compliance with applicable regulatory requirements for
outsourced processes.
14.34.3 Documentation requirements
14.3.14.3.1 General
The maintenance management programme documentation shall include:
a) documented quality objectives (see 5.1.15.2.1););
b) documented procedures and records required by this document;
c) documents, including records, determined by the organization to be necessary to ensure the
effective planning, operation, and control of its processes;
d) other documentation specified by applicable;
NOTE Applicable regulatory requirements;requirement can require specific documentation.
e) risk registry/assessments;
f) method statements.
14.3.24.3.2 Control of documents
Records are a special type of document and shall be controlled according to the requirements
given in 4.3.34.3.3.
A documented procedure shall define the controls needed to:
a) review and approve documents for adequacy prior to issue;
b) review, update as necessary and re-approve documents;
c) ensure that the current revision status of and changes to documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin, determined by the organization to be necessary for
the planning and operation of the maintenance management system, are identified and their
distribution controlled;
g) prevent deterioration or loss of documents;
h) prevent the unintended use of obsolete documents and apply suitable identification to them.
The HDO shall ensure that changes to documents are reviewed and approved either by the original
approving function or another designated function that has access to pertinent background
information upon which to base its decisions.
The HDO shall define the period for which at least one copy of obsolete documents shall be
retained.
14.3.34.3.3 Control of records
Records shall be maintained to provide evidence of conformity to requirements of this
specificationdocument and of the effectiveness operation of the maintenance management
programme.
The HDO shall document procedures to define the controls needed for the identification, critical
review, approval, storage, security and integrity, retrieval, retention time and disposition of
records.
Records shall remain legible, readily identifiable, and retrievable. Changes to a record shall remain
identifiable.
The HDO shall retain the records for at least the lifetime of the medical device as defined by the
manufacturer, but not less than two years from the medical device decommissioning.
NOTE Specific regulatory requirements can apply that define the length of time for which records need
to be kept.
14.3.44.3.4 Maintenance management information system (MMIS)
The HDO shall ensure an MMIS is established to manage all aspects of the maintenance
management programme. MMIS shall be maintained and updated.
BES shall train all relevant parties to use MMIS.
The MMIS shall be accessible to authorized users and it shall consist of, but is not limited to, the
following modules and be accessible to authorized users:
a) asset register module,;
b) work order module,;
c) preventive maintenance module,;
d) maintenance history module and;
e) supplier-client register module or approved supplier list (ASL)), where quality management
system (QMS) is present within the HDO.
If applicable, data back-up shall be carried out at periodic intervals.
14.3.54.3.5 Technical library
14.3.5.14.3.5.1 The HDO shall establish, maintain and manage a library of technical
documents. The library shall be accessible to respective personnel and consist of documents such
as:
a) operation and maintenance manuals,;
b) instructions for use,;
c) drawings,;
d) software,;
e) guidance documents and regulations,;
f) training materials,;
g) other related documents.
155 Management responsibility
15.15.1 Planning
15.1.15.1.1 Quality objectives
The HDO shall ensure that quality objectives, including those needed to meet applicable
regulatory requirements and requirements for the maintenance management programme, are
established at relevant functions and levels within the organization.
The quality objectives shall be measurable.
15.1.25.1.2 Maintenance management programme planning
The HDO shall ensure that:
a) the planning of the maintenance management programme is carried out in order to meet the
requirements given in 4.14.1,, as well as the quality objectives;
b) the integrity of the mai
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