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A collection of featured documents from our library that are popular among our users or otherwise noteworthy.

BSI BS EN 556-1:2024

Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' -- Part 1. Requirements for terminally sterilized medical devices

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BSI BS EN ISO 20417:2026

Medical devices. Information to be supplied by the manufacturer

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BSI BS EN ISO 14155:2026

Clinical investigation of medical devices for human subjects. Good clinical practice

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BSI BS EN ISO 10993-1:2025

Biological evaluation of medical devices -- Evaluation and testing

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BSI BS EN 60601-1:2006+A13:2024

Medical electrical equipment -- General requirements for safety

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BSI BS EN 17141:2020

Cleanrooms and associated controlled environments. Biocontamination control

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BSI BS EN ISO 15223-1:2021+A1:2025

Medical devices. Symbols to be used with information to be supplied by the manufacturer. General requirements

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BSI BS EN ISO 10993-7:2026

Biological evaluation of medical devices -- Ethylene oxide sterilization residuals

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BSI BS EN ISO 13485:2016+A11:2021

Medical devices. Quality management systems. Requirements for regulatory purposes

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BSI BS EN ISO 11137-1:2026

Sterilization of health care products. Radiation -- Requirements for the development, validation and routine control of a sterilization process for medical devices

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All Documents

BSI HB 10175:1999
The Excellence Routefinder
BSI HB 10175:1999

The Excellence Routefinder

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BSI HB 10176:1999
The IFSA Code. Sealing apertures and service penetrations to maintain fire resistance
BSI HB 10176:1999

The IFSA Code. Sealing apertures and service penetrations to maintain fire resistance

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BSI HB 10177:2000
Mitchell's Structure & Fabric - Part 1
BSI HB 10177:2000

Mitchell's Structure & Fabric - Part 1

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BSI HB 10178:2000
Hot and Cold Water Supply. 2nd edition
BSI HB 10178:2000

Hot and Cold Water Supply. 2nd edition

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BSI HB 10179:2000
Mitchell's Structure & Fabric - Part 2
BSI HB 10179:2000

Mitchell's Structure & Fabric - Part 2

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BSI HB 10181:2001
Transition to ISO 9001:2000
BSI HB 10181:2001

Transition to ISO 9001:2000

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BSI HB 10182:2001
Environmental Management Systems for SMEs
BSI HB 10182:2001

Environmental Management Systems for SMEs

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BSI HB 10183:2001
Effective EMS Auditing
BSI HB 10183:2001

Effective EMS Auditing

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BSI HB 10185:2001
Eco-management Accounting
BSI HB 10185:2001

Eco-management Accounting

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BSI HB 10187:2001
Reliability, Maintainability and Risk. 6th edition
BSI HB 10187:2001

Reliability, Maintainability and Risk. 6th edition

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BSI HB 10188:2001
ISO 9001:2000 for Small Businesses. 2nd edition
BSI HB 10188:2001

ISO 9001:2000 for Small Businesses. 2nd edition

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BSI HB 10189:2001
ISO 9001:2000 in Brief
BSI HB 10189:2001

ISO 9001:2000 in Brief

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BSI HB 10190:2001
IMS: The framework (Integrated Management Systems Series)
BSI HB 10190:2001

IMS: The framework (Integrated Management Systems Series)

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BSI HB 10191:2002
IMS: Implementing and operating (Integrated Management Systems Series)
BSI HB 10191:2002

IMS: Implementing and operating (Integrated Management Systems Series)

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BSI HB 10192:2001
Guide to BS EN 13549. Cleaning services, basic requirements and recommendations for quality measuring systems
BSI HB 10192:2001

Guide to BS EN 13549. Cleaning services, basic requirements and recommendations for quality measuring systems

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BSI HB 10194:2022
Guidance notes 3. Inspection and testing. It contains clear guidance on how to apply the relevant sections of BS 7671 and has been fully updated to BS 7671:2018+A2:2022
BSI HB 10194:2022

Guidance notes 3. Inspection and testing. It contains clear guidance on how to apply the relevant sections of BS 7671 and has been fully updated to BS 7671:2018+A2:2022

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BSI HB 10196:2001
Effective Document Management. Unlocking corporate knowledge
BSI HB 10196:2001

Effective Document Management. Unlocking corporate knowledge

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BSI HB 10197:2001
The Essentials of Project Management. 2nd edition
BSI HB 10197:2001

The Essentials of Project Management. 2nd edition

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BSI HB 10198:2001
Implementing ISO 9000:2000
BSI HB 10198:2001

Implementing ISO 9000:2000

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BSI HB 10201:2001
16Th Edition of the Wiring Regulations, Guidance Note 3. Inspection and Testing
BSI HB 10201:2001

16Th Edition of the Wiring Regulations, Guidance Note 3. Inspection and Testing

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BSI HB 10202:2002
A Guide for the Adoption of ISO 9001:2000 in Healthcare
BSI HB 10202:2002

A Guide for the Adoption of ISO 9001:2000 in Healthcare

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BSI HB 10203:2002
A Guide for the Adoption of ISO 9001:2000 for Industries within the Foodchain
BSI HB 10203:2002

A Guide for the Adoption of ISO 9001:2000 for Industries within the Foodchain

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BSI HB 10204:2002
Handbook on the Wiring Regulations. 3rd edition
BSI HB 10204:2002

Handbook on the Wiring Regulations. 3rd edition

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BSI HB 10205:2002
Wiring Regulations: Guidance Note 1: Selection and erection of equipment. 4th edition
BSI HB 10205:2002

Wiring Regulations: Guidance Note 1: Selection and erection of equipment. 4th edition

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BSI HB 10206:2002
Wiring Regulations: Guidance Note 2: Isolation and switching. 4th edition
BSI HB 10206:2002

Wiring Regulations: Guidance Note 2: Isolation and switching. 4th edition

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