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BS 70000:2017

Current
Current

The latest, up-to-date edition.

Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-31-2017

Foreword
0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Annexes
Annex A (informative) - Medical physics, clinical
        engineering and associated science services
        in healthcare
Bibliography

Describes requirements for quality, safety and competence in medical physics, clinical engineering and associated science services, including the development and manufacture of associated products, in healthcare, which include: a) the optimization and delivery of diagnostic and therapeutic procedures; b) provision of expert professional advice; c) project management; d) provision of scientific and technical support for the procurement, governance and life cycle management of medical devices; e) the repair, maintenance, testing, metrological confirmation and quality assurance of equipment and facilities within a healthcare environment; f) design and manufacture of devices and patient aids; g) radiopharmaceutical production; h) healthcare science education and training; and i) innovation, research and development.

This British Standard specifies requirements for quality, safety and competence in medical physics, clinical engineering and associated science services, including the development and manufacture of associated products, in healthcare, which include: the optimization and delivery of diagnostic and therapeutic procedures; provision of expert professional advice; project management; provision of scientific and technical support for the procurement, governance and life cycle management of medical devices; the repair, maintenance, testing, metrological confirmation and quality assurance of equipment and facilities within a healthcare environment; design and manufacture of devices and patient aids; NOTE See “Further reading?? in the Bibliography for standards covering the design and manufacture of devices. radiopharmaceutical production; healthcare science education and training; and innovation, research and development. It specifies a framework for good practice in service delivery, training and innovation research and development, including the roles, responsibilities, activities, facilities and equipment that are required for the delivery of such healthcare science services and associated products for the benefit of patients. This British Standard can be used: by service providers in developing their quality management systems and assessing the performance of their service and the competence of their staff; and for confirming or recognizing the competence of these professional services by service users (including patients), regulating authorities and accreditation bodies. Services for the maintenance of buildings and environmental conditions of healthcare facilities are not covered by this British Standard, although its main principles can be used to improve the provision of such services.

Committee
CH/100
DevelopmentNote
Supersedes 15/30323396 DC. (02/2017)
DocumentType
Standard
Pages
58
PublisherName
British Standards Institution
Status
Current
Supersedes

BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN ISO 10012:2003 Measurement management systems. Requirements for measurement processes and measuring equipment
BS EN ISO/IEC 17000:2004 Conformity assessment. Vocabulary and general principles
BS 6000-1:2005 Guide to the selection and usage of acceptance sampling systems for inspection of discrete items in lots General guide to acceptance sampling
BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
BS EN ISO/IEC 17065:2012 Conformity assessment. Requirements for bodies certifying products, processes and services
BS ISO 37500:2014 Guidance on outsourcing
BS 13500:2013 Code of practice for delivering effective governance of organizations
BS EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices Roles, responsibilities and activities
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
BS EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
BS EN ISO/IEC 17020:2012 Conformity assessment. Requirements for the operation of various types of bodies performing inspection
BS EN 31010:2010 Risk management. Risk assessment techniques
ANSI/AAMI EQ89:2015 GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES
BS ISO 55000:2014 Asset management Overview, principles and terminology
BS EN ISO 9000:2015 Quality management systems. Fundamentals and vocabulary
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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