WORKSHOP PARA USUÁRIOS Convênio FNS/USP 2209/2008 … ISO … · Convênio FNS/USP 2209/2008 Normas Técnicas, Gerenciamento de Risco, Metrologia e Utilização de Produtos para

WORKSHOP PARA USUÁRIOS

Convênio FNS/USP 2209/2008

Normas Técnicas, Gerenciamento de Risco,

Metrologia e Utilização de Produtos para a Saúde:

Porque participar e se envolver?

Profº Dr. José Carlos Teixeira de Barros Moraes Laboratório de Engenharia Biomédica/Escola Politécnica da USP

Estrutura e estado atual da produção

normativa da ISO relativa a produtos para a

saúde

INTERNALIZAÇÃO BRASILEIRA DE NORMAS

TÉCNICAS NO SETOR DE PRODUTOS PARA A

SAÚDE

José Carlos T. B. Moraes

ISO - International Organization for StandardizationSome examples of ISO technical committees

ISO - International Organization for StandardizationSome examples of ISO technical committees

ISO - International Organization for StandardizationHealth and Medicine ISO technical committees

ISO - International Organization for StandardizationTC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use

TC 76 - Transfusion, infusion and injection equipment for medical and pharmaceutical use

• Secretariat: DIN

• Secretary: Dr.-Ing. Vera Sattelmayer

• Chairperson: Dr. Bernd Mathieu (Germany) until end 2009

• Creation date: 1951

Scope:

Standardization of transfusion, infusion and injection equipment for medical and pharmaceutical use; terms

and definitions for such equipment; specifications for quality and performance of materials and components.

Standardization of containers (such as infusion bottles, injection vials, ampoules, glass cylinders, cartridges,

prefillable syringes, etc.) and devices (such as giving sets, blood collecting tubes, etc.) as well as pertinent

primary and secondary packaging and functional components (such as elastomeric closures, caps, pipettes

and accessories) for medical and pharmaceutical use.

Excluded:

• performance requirements of metered devices and supplies intended for self-administration of

medicinal products, non-prefilled syringes and needles and intravascular catheters, covered by ISO/TC 84;

• devices intended for respiratory therapy, covered by ISO/TC 121;

• dental cartridge syringe holder, covered by ISO/TC 106.

Total number of published ISO standards related to the TC and its SCs: 58

Number of published ISO standards under the direct responsibility of TC 76: 58

Participating countries: 17

Observing countries: 24


Subcommittee/Working Group Title

TC 76/WG 1 Plastic devices

TC 76/WG 2 Joint between ISO/TC 76 and ISO/TC 84: Glass

equipment

TC 76/WG 3 Secondary packaging closure components and

accessories

TC 76/WG 4 Elastomeric parts

TC 76/WG 5 Blood collection systems

TC 76/WG 6 Primary packaging materials for medicinal products

TC 76/WG 7 Non--electrically driven portable infusion devices

Joint working groups under the responsibility of another committee:

TC 84/WG 5 Joint TC 84-TC 76-TC 121/SC 3 WG : Pulmonary devices


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Standards under development



ISO - International Organization for StandardizationTC 121 - Anaesthetic and respiratory equipment

TC 121 - Anaesthetic and respiratory equipment

Secretariat: ANSI

Secretary: Ms. Debra Milamed

Chairperson: Dr. Ronald Greenbaum (United Kingdom) until end 2007

Creation date: 1966

Scope:

Standardization of anaesthetic and respiratory equipment and supplies, related devices and supply systems.

Total number of published ISO standards related to the TC and its SCs:

77

Participating countries:

26

Observing countries:

22

ISO committees in liaison:

TC 58, TC 198, TC 210, TC 215

IEC committees in liaison:

IEC/TC 62, IEC/SC 62D



TC 121/CAGChairman Advisory Group

The convener can be reached through the secretariat

TC 121/SC 1 Breathing attachments and anaesthetic machines - STANDBY

TC 121/SC 2 Tracheal tubes and other equipment

TC 121/SC 3 Lung ventilators and related equipment

TC 121/SC 4 Anaesthesia terminology

TC 121/SC 6 Medical gas systems

TC 121/SC 8 Suction devices for hospital and emergency care use


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards





ISO - International Organization for StandardizationTC 150 - Implants for surgery

TC 150

Implants for surgery

Secretariat: DIN

Secretary: Dr.-Ing. Gabriele Tröscher

Chairperson: Mr. J.P. Hallett (United Kingdom) until end 2010

Creation date:

Scope:

Standardization in the field of implants for surgery 1) and their requiredinstrumentation, covering

terminology, specifications andmethods of tests for all types of implants, and for thematerials

both basic and composite used in their manufactureand application.

1) Objects or devices which are surgically implantedin the body either temporarily or

permanently for diagnosticor therapeutic purposes.







TC 150/WG 7

Fundamental standards

The convener can be reached through the

secretariat

TC 150/WG 8

Breast implants - STANDBY


secretariat

TC 150/WG 10

Data on implanted and retrieved devices


secretariat

TC 150/SC 1 Materials

TC 150/SC 2Cardiovascular implants and

extracorporeal systems

TC 150/SC 3 Neurosurgical implants

TC 150/SC 4 Bone and joint replacements

TC 150/SC 5 Osteosynthesis and spinal devices

TC 150/SC 6 Active implants

TC 150/SC 7 Tissue-engineered medical products


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards


Published standards

ISO - International Organization for StandardizationTC 150 - Implants for surgeryStandards under development




ISO - International Organization for StandardizationTC 157 - Mechanical contraceptives

TC 157 - Mechanical contraceptives

• Secretariat: DSM

• Secretary: Mrs. Roslina Harun

• Chairperson: Dr Eng Long Ong (Malaysia) until end 2011


Scope:

Standardization of mechanical contraceptives.







TC 157/TG 1 Statistical task group

TC 157/CAG Chairman Advisory Group

TC 157/WG 3 Intra-uterine devices

TC 157/WG 10 Minimum burst pressure and burst volume requirements

TC 157/WG 11 Packaging integrity

TC 157/WG 12 Determination of the amount of lubricant

TC 157/WG 13 Stability assessment

TC 157/WG 14 Guidance on the use of ISO 4074 and ISO 23409

TC 157/WG 15 Test methods for the effect of additional lubricants on physical

properties of condoms

TC 157/WG 17 Synthetic condoms

TC 157/WG 18 Female condoms

TC 157/WG 19 Methods for hole detection

TC 157/WG 20 Clinical trials

TC 157/WG 21 Determination of nitrosamines

TC 157/WG 22 Latex barrier membranes

TC 157/WG 23 Natural rubber latex condoms

TC 157/WG 24 Tubal ligation/Fallopian ring


Published standards



ISO - International Organization for StandardizationTC 168 - Prosthetics and orthotics

TC 168 - Prosthetics and orthotics


• Secretary: Dipl.-Ing. Karl Wenzelewski

• Chairperson: Prof. Dr. Manfred Nietert (Germany) until end 2010


Scope:

Standardization in the field of prosthetics and orthotics, covering such aspects as

performance, safety, environmental factors, interchangeability, etc.

Temporary and permanent procedures and devices are included.

Priority is given to standards on prostheses (artificial limbs and auxiliary equipment).







TC 168/WG 1 Nomenclature and classification

TC 168/WG 2 Medical aspects

TC 168/WG 3 Testing


Published standards


Published standards


Published standards

ISO - International Organization for StandardizationTC 170 - Surgical instruments

TC 170 - Surgical instruments


• Secretary: Dipl.-Ing. Karl Wenzelewski

• Chairperson: Prof. Bernd Domres (Germany) until end 2009


Scope:

Standardization in the field of surgical instruments such as forceps, scissors,

scalpels and retractors.

Excluded :

• specific instruments which are dealt with in ISO / TC 106 - Dentistry, and

ISO / TC 150 - Implants for surgery.





ISO - International Organization for StandardizationTC 170 - Surgical instruments

Published standards

ISO - International Organization for StandardizationTC 210 - Quality management and corresponding general aspects for medical devices

TC 210 - Quality management and corresponding general aspects for medical devices

• Secretariat: ANSI

• Secretary: Ms. Hillary Woehrle

• Chairperson: Dr. Eamonn V. Hoxey (United Kingdom) until end 2009


Scope:

Standardization of requirements and guidance in the field of quality management and corresponding general

aspects for medical devices. Standards for small bore connectors.

Excluded:

• generic quality management standards dealt with by ISO / TC 176;

• quality management standards for pharmaceutical products;

• technical requirements for specific types of medical devices (Note: Small bore connectors are

components of a range of medical devices but are not themselves medical devices).

Note:

In order to promote global harmonization the technical committee may also develop standards on general

aspects stemming from the application of quality principles to medical devices, where these are not covered

by the scope of another technical committee.







TC 210/WG 1 Application of quality systems to medical devices

TC 210/JWG 1 Joint ISO/TC 210-IEC/SC 62A WG : Application of risk

management to medical devices

TC 210/JWG 2 Joint ISO/TC 210-IEC/SC 62A WG : Medical device software

TC 210/WG 2 General aspects stemming from the application of quality

principles to medical devices

TC 210/WG 3 Symbols and nomenclature for medical devices

TC 210/JWG 3 Joint ISO/TC 210-IEC/SC 62A WG : Medical device usability

TC 210/JWG 4 Joint ISO/TC 210-IEC/SC 62D: Small bore connectors


Published standards


Published standards



ISO - International Organization for StandardizationTC 212 - Clinical laboratory testing and in vitro diagnostic test systems

TC 212 - Clinical laboratory testing and in vitro diagnostic test systems

• Secretariat: ANSI

• Secretary: Mr. David Sterry

• Chairperson: Dr. Donald M. Powers (USA) until end 2012


Scope:

Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This

includes, for example, quality management, pre- and post-analytical procedures, analytical performance,

laboratory safety, reference systems and quality assurance.

Excluded:

• generic quality management standards dealt with by ISO / TC 176;

• quality management standards for medical devices dealt with by ISO / TC 210;

• reference materials guidelines dealt with by the ISO Committee on Reference Materials

(REMCO);

• conformity assessment guidelines dealt with by the ISO Committee on Conformity assessment

(CASCO).







TC 212/WG 1 Quality and competence in the medical laboratory

TC 212/WG 2 Reference systems

TC 212/WG 3 In vitro diagnostic products

TC 212/WG 4 Antimicrobial susceptibility testing


Published standards


Published standards



ISO - International Organization for Standardization

Fonte de pesquisa: http://www.iso.org

Documents

WORKSHOP PARA USUÁRIOS Convênio FNS/USP 2209/2008 … ISO … · Convênio FNS/USP 2209/2008 Normas Técnicas, Gerenciamento de Risco, Metrologia e Utilização de Produtos para