AAMI 13022 2012
$140.32
ANSI/AAMI/ISO 13022:2012 – Medical products containing viable human cells-Application of risk management and requirements for processing practices
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 71 |
Specifies a procedure to identify the hazards and hazardous situations and to manage the risk associated with viable cellular component(s) of products regulated as medicinal products, biologics, medical devices and active implantable medical devices or combinations thereof. Covers viable human materials of autologous as well as allogeneic human origin.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 13022:2012, Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Table of contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of ANSI/AAMI adoption of ISO 13022:2012 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope |
| 16 | 2 Normative references 3 Terms and definitions |
| 21 | 4 Risk management process 4.1 General |
| 22 | 4.2 Hazards associated with the cellular component 4.2.1 General 4.2.2 Responsibilities 4.2.3 Documentation |
| 23 | 4.2.4 Personnel 4.3 Risk analysis 4.3.1 General |
| 24 | 4.3.2 Intended use and identification of characteristics related to the safety of the cellular component of the product 4.3.3 Identification of hazards |
| 25 | 4.4 Risk evaluation 4.5 Risk control 4.5.1 General 4.5.2 Residual risk evaluation 4.6 Evaluation of overall residual risk acceptability |
| 26 | 4.7 Production and post-production information system |
| 27 | Annex A (informative) Guidance on the application of ISO 13022 A.1 General A.2 Application to sources for human cells and tissues A.3 Application to materials supplied by third parties |
| 28 | Annex B (informative) Graphic representation of the part of the risk management process for cell-based medical products |
| 29 | Annex C (normative) Requirements for donor selection and testing C.1 General C.2 Deceased donors C.2.1 General criteria for exclusion |
| 30 | C.2.2 Additional criteria for deceased child donors C.3 Living donors – General criteria for selection C.3.1 Autologous living donor C.3.2 Allogeneic living donor |
| 31 | C.4 Biological tests required for donors |
| 32 | C.5 Requirements to be met for determining biological markers C.5.1 General C.5.2 Hemodilution C.5.3 Sampling from deceased donors C.5.4 Sampling from living donors |
| 34 | Annex D (informative) Guidance for tissue procurement D.1 General D.2 Consent and donor identification D.3 Donor evaluation for allogeneic donors D.4 Procurement procedures for tissues and cells |
| 35 | D.5 Donor documentation |
| 37 | Annex E (normative) Requirements for handling of cells and tissue during manufacture E.1 General E.2 Specifications E.3 Documentation E.4 Combined cell-based medical products |
| 38 | E.5 Manufacturing area E.6 Cell handling procedures E.6.1 General E.6.2 Organ/tissue dissociation E.6.3 Isolation of the cell population of interest |
| 39 | E.6.4 Cell culture E.6.5 Cell modification E.6.6 Cells cultured in or on a matrix/device/scaffold E.7 In-process controls E.8 Batch definition |
| 40 | Annex F (normative) Requirements for packaging and labeling F.1 General F.2 Specifications F.3 Documentation F.4 Chemical properties of the packaging container F.5 Physical properties of the packaging container F.6 Contamination |
| 41 | F.7 Labeling |
| 42 | F.8 Requirements for primary packaging F.8.1 Primary packaging used after the procurement or during the process (intermediaries or finished products) F.8.2 Primary packaging of the blood samples obtained from the donor F.8.3 Primary packaging of the samples used for the quality control of the products F.9 Shipping container |
| 43 | F.10 Packaging of waste products with biological risk resulting from the procurement or the processing |
| 44 | Annex G (informative) Guidance for transport G.1 General |
| 45 | G.2 Specifications G.3 Validation G.4 Documentation G.5 Cross-contamination G.6 Contractual agreements |
| 46 | G.7 Preparation of the transport container G.8 Transport of the products G.9 Responsibilities of the manufacturer |
| 47 | G.10 Material and hygiene G.11 Packaging and labeling of the transport container G.12 Documents relating to transport |
| 48 | G.13 Transport conditions and duration G.14 Delivery and control at reception G.15 Reception of the tissue and cells |
| 50 | Annex H (informative) Guidance for storage H.1 General H.2 Facility H.3 Personnel |
| 51 | H.4 Specification H.5 Qualification and validation H.6 Monitoring and documentation H.7 Cross-contamination |
| 52 | H.8 Storage of non-cellular material H.9 Storage of waste with biological risk/biohazard H.10 Stability |
| 53 | H.11 Storage conditions for the final product |
| 54 | Annex I (normative) Requirements for traceability I.1 General I.2 Specific requirements |
| 55 | Annex J (normative) Risk reduction measures relating to contamination with viruses and other infectious agents such as TSE J.1 General J.2 Source of virus/TSE contamination J.2.1 Human tissues and cells |
| 56 | J.2.2 Processing aids J.3 Risk reduction methods J.3.1 Testing of donors of human tissue and cells |
| 57 | J.3.2 Testing of cell banks J.3.3 Selection of appropriate raw materials and/or reagents |
| 58 | Annex K (informative) Guidance relating to hazards caused by the tumorigenic potential of human cells or tissues used for the production of medical products |
| 59 | Annex L (informative) Guidance relating to microbiological contamination L.1 General L.2 Detection of microbiological contamination of the cell or tissue raw material L.3 Prevention of microbiological contamination of the product during manufacture |
| 60 | Annex M (informative) Guidance relating to potential adverse effects of non-cellular residues of the product M.1 General M.2 Non-clinical testing M.3 Combined products |
| 61 | Annex N (normative) Requirements relating to potential adverse effects of the cellular components of a medical product N.1 General N.2 Non-clinical testing for adverse effects |
| 63 | Annex O (informative) Guidance for the characterization of the cellular components of a medical product O.1 General O.2 Identity O.3 Cell purity |
| 64 | O.4 Process-derived impurities O.5 Viability O.6 Potency O.6.1 General |
| 65 | O.6.2 Cells for tissue repair/regeneration O.6.3 Cells with primarily metabolic/pharmacological function |
| 66 | O.6.4 Cells for immunotherapy |
| 67 | Annex P (informative) Clinical evaluation and testing |
| 68 | Bibliography International |
| 69 | Europe |
| 70 | Japan USA |
