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  • BS PAS 84(2008) : 2008

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    REGENERATIVE MEDICINE - GLOSSARY

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-03-2012

    Language(s):  English

    Published date:  01-01-2008

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 General
    3 Cell and tissue components
    4 Non-cellular components
    5 Cell and tissue procurement
    6 Measurement and analysis
    7 Manufacturing and production
    8 Clinical trials
    Annexes
    Annex A (informative) - Regulatory terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes terms and definitions: a) associated with the naming of types of regenerative medicine products and therapies; b) that describe materials, processes, methodologies and applications within regenerative medicine.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher British Standards Institution
    Status Superseded

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS PAS 93(2011) : 2011 CHARACTERIZATION OF HUMAN CELLS FOR CLINICAL APPLICATIONS - GUIDE
    ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    10/30203224 DC : 0 BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
    BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    BS PAS 83(2006) : 2006 GUIDANCE ON CODES OF PRACTICE, STANDARDISED METHODS AND REGULATIONS FOR CELL-BASED THERAPEUTICS
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
    BS EN ISO 14644-1:2015 Cleanrooms and associated controlled environments Classification of air cleanliness by particle concentration
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