Foreword

This PAS was commissioned by the UK Department for Business, Innovation and Skills (BIS). Its development was facilitated by BSI Standards Limited and published under licence from The British Standards Institution. It came into effect on 30 March 2012.

Acknowledgement is given to the technical author, Emily Culme-Seymour, and the following organizations that were involved in the development of this vocabulary as members of the Steering Group:

• Anthony Nolan (Alejandro Madrigal)
• CellData Services (Alison Wilson)
• Consulting on advanced biologicals (Christopher Bravery)
• Department for Business, Innovation and Skills (Michael Skwarek and Sitali Simwami)
• LGC (Julian Braybrook)
• London Regenerative Medicine Network (Emily Culme-Seymour)
• National Institute for Biological Standards and Control (Glyn Stacey)
• National Physical Laboratory (Max Ryadnov)
• University College London (Chris Mason)
• University of Oxford (Paul Fairchild)

Acknowledgement is also given to those organizations and individuals that submitted comments during the public consultation.

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, and any amendments arising from the review will be published as an amended PAS and publicized in Update Standards.

This PAS is not to be regarded as a British Standard. It will be withdrawn upon publication of its content in, or as, a British Standard.

The PAS process enables a specification to be rapidly developed in order to fulfil an immediate need in industry. A PAS may 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.

Supersession

This PAS supersedes PAS 84:2008, which is withdrawn.

Information about this document

This is a full revision of the PAS and introduces the following principal changes:

• update of existing terms and definitions for accuracy and relevance
• addition of new terms that have appeared within the research, clinical, bioprocessing and regulatory space since the last revision
• update of the annex on regulatory terms to reflect changes in legislation and include regulatory terms used in the USA as well as in the UK and Europe
• addition of an annex on finance terms that are likely to be of use to the cell therapy and regenerative medicine community

Relationship with other publications

This PAS provides a set of terms and definitions that is of relevance to the cell therapy and regenerative medicine industry.

It includes definitions of terms used in:

• PAS 83 , Developing human cells for clinical applications in the European Union and the United States of America — Guide
• PAS 93 , Characterization of human cells for clinical applications — Guide

Where possible, an attempt has been made to use terms and definitions that have been defined in existing standards, in particular ASTM F2312-11, Standard terminology relating to tissue engineered medical products.

A number of regulations exist that are relevant to the field of cell therapy and regenerative medicine. These regulations contain terms that are defined in some detail. In some instances regulatory definitions have been included verbatim. However, in order for this PAS to achieve its intended objective, more succinct and precise definitions consistent with regulations have been developed.

Presentational conventions

The terms and definition in the PAS are presented in roman (i.e. upright) type.

Commentary, explanation and general informative material is presented in smaller italic type.

When terms defined in this PAS are used in the definition or notes of another term, they are shown in bold type.

Where a term has been given a meaning narrower than its generally accepted meaning, a qualification has been included in angular brackets at the start of the definition denoting the context within which it has been defined, i.e. <…>.

Spelling conforms to The Shorter Oxford English Dictionary. If a word has more than one spelling, the first spelling in the dictionary is used.

Feedback

Feedback on the technical content of this PAS can be submitted through the BSI Document Feedback system http://feedback.bsigroup.com.

Any feedback received will be reviewed when developing future revisions of this document.

Contractual and legal considerations

Attention is drawn to the following statutory regulations.

a) European Directive 2001/83/EC relating to medicinal products for human use (and amendments) [1]
b) European Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [2] implemented in the UK by Human Tissue (Quality and Safety for Human Application) Regulations 2007 [3]
c) European Directive 2010/45/EU on standards of quality and safety of human organs intended for transplantation [4]
d) European Regulation No. 1394/2007 on advanced therapy medicinal products [5]
e) Human Fertilisation and Embryology Act 1990 (and amendments) [6]
f) Human Tissue Act 2004 [7]
g) Human Tissue (Scotland) Act 2006 (and amendments) [8]

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a PAS cannot confer immunity from legal obligations.

PAS 84:2012

Cell therapy and regenerative medicine. Glossary

Published:

30 Mar 2012

Withdrawn:

21 Mar 2022