CSA Z900 PACKAGE : 2012

CAN/CSA-Z900.1-12, Cells, tissues, and organs for
                  transplantation: General requirements
Preface
1 Scope
2 Reference publications
3 Definitions and abbreviations
4 Establishment requirements
5 Facilities
6 Standard operating procedures
7 Records and tracking
8 Infection control and safety
9 Disposal of cells, tissues, and organs
10 Consent
11 Compensation
12 Donor suitability assessment
13 Donor screening
14 Testing
15 Retrieval, preparation, preservation, and storage
16 Labels, inserts, and accompanying documentation
17 Quarantine and release
18 Distribution
19 Error, accident, and adverse reaction investigation and
   reporting
20 Continuous improvement
Annexes
A (informative) - Developmental background and history
  of the CSA general requirements standard and its subsets
B (informative) - Ethics: Cells, tissues, and organs for
  transplantation
C (normative) - Labelling requirements
D - Placeholder
E (normative) - Factors and behaviours associated with a
  higher risk of Human Immunodeficiency Virus (HIV),
  Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
F (informative) - Bibliography
CAN/CSA-Z900.2.1-12, Tissues for assisted reproduction
Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions and abbreviations
4 Establishment requirements
5 Facilities
6 Standard operating procedures
7 Records and tracking
8 Infection control and safety
9 Disposal of tissues for assisted reproduction
10 Consent
11 Compensation
12 Donor suitability assessment
13 Donor screening
14 Testing
15 Retrieval, preparation, preservation, and storage
16 Labels, inserts, and accompanying documentation
17 Quarantine and release
18 Distribution
19 Adverse event monitoring and recalls
CAN/CSA-Z900.2.2-12, Tissues for transplantation
Preface
1 Scope
2 Reference publications
3 Definitions and abbreviations
4 Establishment requirements
5 Facilities
6 Standard operating procedures
7 Records and tracking
8 Infection control and safety
9 Disposal of tissues
10 Consent
11 Compensation
12 Donor suitability assessment
13 Donor screening
14 Testing
15 Retrieval, preparation, preservation, and storage
16 Labels, inserts, and accompanying documentation
17 Quarantine and release
18 Distribution
19 Error, accident, and adverse reaction investigation
   and reporting
20 Continuous improvement
CAN/CSA-Z900.2.3-12, Perfusable organs for transplantation
Preface
1 Scope
2 Reference publications
3 Definitions and abbreviations
4 Establishment requirements
5 Facilities
6 Standard operating procedures
7 Records and tracking
8 Infection control and safety
9 Disposal of organs
10 Consent
11 Compensation
12 Donor suitability assessment
13 Donor screening
14 Testing
15 Retrieval, processing, preservation, and storage
16 Labels, inserts, and accompanying documentation
17 Quarantine and release
18 Distribution
19 Error, accident, and adverse reaction investigation
   and recall
20 Continuous improvement
CAN/CSA-Z900.2.4-12, Ocular tissues for transplantation
Preface
1 Scope
2 Reference publication
3 Definitions and abbreviations
4 Establishment requirements
5 Facilities
6 Standard operating procedures (SOPs)
7 Records and tracking
8 Infection control and safety
9 Disposal of tissues
10 Consent
11 Compensation
12 Donor suitability assessment
13 Donor screening
14 Testing
15 Retrieval, preservation, and storage
16 Labels, package inserts, and accompanying documentation
17 Quarantine and release
18 Distribution
19 Error, accident, and adverse reaction investigation and
   reporting
20 Continuous improvement
CAN/CSA-Z900.2.5-12, Lymphohematopoietic cells for
                    transplantation
Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions and abbreviations
4 Establishment requirements
5 Facilities
6 Standard operating procedures
7 Records and tracking
8 Infection control and safety
9 Disposal of lymphohematopoietic cells
10 Consent
11 Compensation
12 Donor suitability assessment
13 Donor screening
14 Testing
15 Collection, processing, preservation, and storage
16 Labels, package inserts, and accompanying documentation
17 Quarantine and release
18 Distribution
19 Error, accident, and adverse reaction investigation and
   reporting
20 Continuous improvement

Includes: - CAN/CSA-Z900.1-12, Cells, tissues, and organs for transplantation: General requirements - CAN/CSA-Z900.2.1-12, Tissues for assisted reproduction - CAN/CSA-Z900.2.2-12, Tissues for transplantation - CAN/CSA-Z900.2.3-12, Perfusable organs for transplantation - CAN/CSA-Z900.2.4-12, Ocular tissues for transplantation - CAN/CSA-Z900.2.5-12, Lymphohematopoietic cells for transplantation