Foreword

This PAS was sponsored by Abbott Diabetes Care Ltd. Its development was facilitated by BSI Standards Limited and it was published under licence from The British Standards Institution. It came into effect on 30 November 2025.

Acknowledgement is given to Claire Thompson, Abbott Diabetes Care Ltd., as the technical author, and the following organizations that were involved in the development of this PAS as members of the Steering Group:

Abbott Diabetes Care Ltd.
BSI Regulatory Services – Active Medical Devices
Dexcom, Inc.
Diabetes UK
Diabettech
European Diabetes Forum (EUDF)
Foundation for Diabetes Research in Older People
Institute for Diabetes Technology Ulm (IfDT)
Insulet Corporation
Lancaster University
University of Leicester
U.S. Food and Drug Administration (FDA)

Acknowledgement is also given to the members of a wider review panel who were consulted in the development of this PAS.

The British Standards Institution retains ownership and copyright of this PAS. BSI Standards Limited, as the publisher of the PAS, reserves the right to withdraw or amend this PAS on receipt of authoritative advice that it is appropriate to do so. This PAS will be reviewed at intervals not exceeding two years.

This PAS is not to be regarded as a British Standard. It will be withdrawn in the event it is superseded by a British Standard.

The PAS process enables a standard to be rapidly developed in order to fulfil an immediate stakeholder need. A PAS can be considered for further development as a British Standard, or constitute part of the UK input into the development of a European or international standard.

Information about this document

Copyright is claimed in definitions 3.1.7, 3.1.8and 3.1.9. The content has been reproduced with the permission of the European Committee for Standardization (CEN). Copyright remains with CEN. All rights reserved.

Copyright is claimed in 6.4.1, 8.2, 8.3, 10.2.3a), 10.2.3c), 10.2.3e) and 10.2.3f). The copyright holder is the United States Federal Government, Federal Register [1].

This publication can be withdrawn, revised, partially superseded or superseded. Information regarding the status of this publication can be found in the Standards Catalogue on the BSI website at knowledge.bsigroup.com, or by contacting the Customer Services team.

Where websites and webpages have been cited, they are provided for ease of reference and are correct at the time of publication. The location of a webpage or website, or its contents, cannot be guaranteed.

Use of this document

Assessed capability. Users of this PAS are advised to consider the desirability of adopting a quality management system in accordance with BS EN ISO 13485.

It has been assumed in the preparation of this PAS that the execution of its provisions will be entrusted to appropriately qualified and experienced people, for whose use it has been produced.

Presentational conventions

The provisions of this document are presented in roman (i.e. upright) type. Its requirements are expressed in sentences in which the principal auxiliary verb is “shall”.

Commentary, explanation and general informative material is presented in smaller italic type, and does not constitute a normative element.

Where words have alternative spellings, the preferred spelling of the Shorter Oxford English Dictionary is used (e.g. “organization” rather than “organisation”).

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a PAS cannot confer immunity from legal obligations.

In particular, attention is drawn to the following specific Acts and regulations:

Medical Devices Regulations 2002 [2]1);
UK General Data Protection Regulation [3];
Data Protection Act 2018 [4];
Medical Device Regulation (EU) 2017/745 [5];
Regulation for Electronic Instructions for Use of Medical Devices (EU) 2021/2226 [6];
Radio Equipment Directive 2014/53/EU [7]; and
Radio Equipment Regulations 2017 [8].

Introduction

Continuous glucose monitoring (CGM) systems are designed to automatically measure glucose levels in interstitial fluid at frequent intervals over a period of time. A CGM system typically consists of a sensor, either worn on the body or implanted, and a digitally connected receiver. Some models also include a separate transmitter.

When used as intended, CGM systems allow users to frequently or continuously monitor their glucose levels. The glucose measurements can be used to guide treatment decisions aimed at managing the concentration of glucose present in the blood.

CGM systems are primarily used by individuals affected by diabetes mellitus to support diabetes management. Diabetes mellitus is a condition characterized by insufficient insulin production or insulin resistance, resulting in elevated blood glucose levels that can lead to both acute and long-term health complications.

CGM systems can also be used to manage other diseases or medical conditions relating to glycaemic control.

Some CGM systems incorporate configurable alerts and alarms to notify users of glucose levels outside clinically defined thresholds. These notifications, delivered via sound, vibration or visual cues, help enable timely user response to hypoglycaemia or hyperglycaemia and can be integral to system safety and usability depending on the system design and intended purpose.

As technology has evolved and CGM systems have become central to the management of diseases and medical conditions related to glycaemic control, it is critical for user safety to have robust clinical data to demonstrate the accuracy and clinical performance of the CGM system throughout the wear period. It is also critical for CGM systems to be designed to protect sensitive health data, safeguard systems from unauthorized access or misuse and preserve data integrity, particularly where CGM systems are digitally connected to mobile and cloud-based applications, and other medical devices, such as insulin pumps.

1 Scope

This PAS specifies requirements for continuous glucose monitoring (CGM) systems intended to be used alone, or in conjunction with, digitally connected medical devices for the purpose of managing diseases or medical conditions related to glycaemic control by lay persons and healthcare professionals.

In particular, requirements relate to:

design verification and validation procedures for demonstrating safety and analytical and clinical performance of CGM systems;
secure software lifecycle principles and the management of cybersecurity risks and threats to CGM systems; and
the provision of information on CGM performance characteristics supplied by the manufacturer to CGM users.

This PAS does not:

provide a comprehensive evaluation of all possible factors that affect the performance of CGM systems;
pertain to glucose concentration measurement for the purpose of diagnoses of a medical condition or disease relating to glycaemic control, including diabetes mellitus;
address the medical aspects of diabetes mellitus management;
apply to in vitro blood glucose monitoring devices; or
apply to CGM systems that do not have a medical purpose, including products intended for wellness and fitness trackers.
NOTE Although this PAS applies to CGM system safety and performance in the UK, it might be useful as a benchmark for other markets.

The PAS is intended to be used by manufacturers of CGM systems, and is expected to be of interest to organizations (e.g. regulatory authorities and conformity assessment bodies) responsible for assessing the performance of these systems.

2 Normative references

3 Terms, definitions and abbreviated terms

3.1 Terms and definitions

3.2 Abbreviated terms

4 Design and development

4.1 General

4.2 Metrological traceability

4.3 Manufacturing controls and design transfer

5 Safety and reliability testing

5.1 Biological evaluation

5.2 Software lifecycle

5.3 Basic safety and essential performance

5.4 Sterilization and packaging

6 Analytical and clinical performance evaluation

6.1 General

6.2 Clinical investigation

6.3 Minimum CGM system accuracy criteria

6.4 Interference testing

6.5 Sensor wear period evaluation

7 User performance evaluation

7.1

7.2

8 Data transmission and connected device performance

8.1

8.2

8.3

8.4

9 Cybersecurity and data privacy

9.1 Secure by design

9.2 Cybersecurity risk controls for device function and communication

9.3 Protection of personal data

10 Information supplied by the manufacturer

10.1 General

10.2 Performance characteristics

10.2.1

10.2.2

10.2.3

10.3 Provision of IFU

Bibliography

PAS 2600:2025

Continuous glucose monitoring systems. Design verification and validation of performance. Specification

Current

Published:

30 Nov 2025