Bulgarian Institute for Standardization
Standards – always a step ahead
Phone: +359 2 8174 523, +359 2 8174 504
E-mail: info@bds-bg.org
1797 Sofia, 13 "Lachezar Stanchev" Str., "Izgrev" Complex
ID number: 175079183, VAT number: BG175079183
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ТК-87

Medical devices

Active

Main committee

Асен Ангелов Димов

Maa Petrova

+359 2 817 4510

maya.duganova@bds-bg.org

Machinery safety

Public documents

Scope

Standardization in the field of medical devices. Standards for: dentistry; sterilizers for medical purposes; lasers and photonic; in vitro diagnostic medical devices; ophthalmic optics; sterilization of medical devices; non-active medical devices; biological evaluation of medical devices; respiratory and anaesthetic equipment; rescue systems; symbols and information provided with medical devices and nomenclature for regulatory data exchange; clinical investigation of medical devices; non-active surgical implants; assistive products for persons with disability; medical products utilizing cells, tissues and/or their derivatives; transfusion, infusion and injection and blood processing equipment for medical and pharmaceutical use; devices for administration of medicinal products and intravascular catheters; anaesthetic and respiratory equipment; implants for surgery; prosthetics and orthotics; optics and photonics; sterilization of health care products; clinical laboratory testing and in vitro diagnostic test systems; surgical instruments and springs; electromedical equipment

Facts and digits

242

New projects

2209

Published standards

1

Meetings

9

Members

Relation to mirrors committee

This BDS/TC is a mirror of the following European and international technical committees

CEN/TC 55

Dentistry


Originator: CEN
P member

CEN/TC 55

Dentistry

Standardization of terminology, methods of test and specifications applicable to materials, instruments, appliances and equipment used in all branches of dentistry.


Originator: CEN

P member

CEN/TC 102

Sterilizers and associated equipment for processing of medical devices


Originator: CEN
P member

CEN/TC 102

Sterilizers and associated equipment for processing of medical devices

This Technical Committee is responsible for the standardization of washer-disinfectors, sterilizers and associated equipment and products used in the processing of medical devices.


Originator: CEN

P member

CEN/TC 123

Lasers and photonics


Originator: CEN
P member

CEN/TC 123

Lasers and photonics

Standardization of systems and components and their use in the fields of lasers and photonics.


Originator: CEN

P member

CEN/TC 140

In vitro diagnostic medical devices


Originator: CEN
P member

CEN/TC 140

In vitro diagnostic medical devices

Standardization in the field of in vitro diagnostic medical devices which are reagents, reagent product, calibrators, control materials, kits, instruments, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: - concerning a physiological or pathological state or; - concerning a congenital abnormality or; - to determine the safety and compatibility with potential recipients, or; - to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. 'Specimen receptacles' are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.


Originator: CEN

P member

CEN/TC 170

Ophthalmic optics


Originator: CEN
P member

CEN/TC 170

Ophthalmic optics

Standardization of products, test methods and instruments used in the field of ophthalmic optics. Industrial eye-protection is excluded. Specific requirements for ophthalmic implants such as intraocular lenses are included in the scope of CEN/TC 170, whereas the general requirements are within the scope of CEN/TC 285.


Originator: CEN

P member

CEN/TC 204

Sterilization of medical devices


Originator: CEN
P member

CEN/TC 204

Sterilization of medical devices

Standardization in the field of validation and monitoring of sterilization processes as used in manufacturing of medical devices.


Originator: CEN

P member

CEN/TC 205

Non-active medical devices


Originator: CEN
P member

CEN/TC 205

Non-active medical devices

Standardization in the field of non-active medical devices with the objective to identify, adopt or adapt ISO or other standards, or if no ISO or other standard exists, to prepare CEN standards supporting applicable European regulations for non-active medical devices. Excluded are non-active medical devices currently within the scopes of other CEN/TCs, but included are (with appropriate liaison with CENELEC) some types of non-active medical devices that use electrical power (from battery or mains supply) for functioning. The excluded areas are, for example, dentistry, sterilizers for medical purposes, in-vitro diagnostic medical devices, sterilization of medical devices, biological evaluation of medical devices, respiratory anaesthetic equipment, chemical desinfectants and antiseptics, clinical investigation of medical devices, non-active surgical implants, assistive products for persons with disability.


Originator: CEN

P member

CEN/TC 206

Biological and clinical evaluation of medical devices


Originator: CEN
P member

CEN/TC 206

Biological and clinical evaluation of medical devices

Standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.


Originator: CEN

P member

CEN/TC 215

Respiratory and anaesthetic equipment


Originator: CEN
P member

CEN/TC 215

Respiratory and anaesthetic equipment

Standardization in the field of anaesthetic and respiratory equipment in particular: - anaesthetic machines; - lung ventilators; - medical gas supply systems and related components; - medical breathing systems; - anaesthetic gas scavenging systems; - related monitoring equipment; - tracheal tubes and related equipment. Excludes equipment currently within the scopes of other CEN/TC, but includes (with appropriate liaison with CENELEC) electrically powered equipment.


Originator: CEN

P member

CEN/TC 239

Rescue systems


Originator: CEN
P member

CEN/TC 239

Rescue systems

To define standards for emergency for emergency medical vehicles and the equipment thereof as well as for first aid equipment, in the interests of providing safe and comfortable transport and preclinical treatment for patients.


Originator: CEN

P member

CEN/TC 257

Symbols and information provided with medical devices and nomenclature for regulatory data exchange


Originator: CEN
P member

CEN/TC 257

Symbols and information provided with medical devices and nomenclature for regulatory data exchange

Standardization of labelling requirements and symbols used in labelling in the field of medical devices and in SC 1 standardization of the identification, coding, nomenclature and data sets for medical devices to facilitate regulatory data exchange.


Originator: CEN

P member

CEN/TC 258

Clinical investigation of medical devices


Originator: CEN
P member

CEN/TC 258

Clinical investigation of medical devices

Standardization in the field of clinical investigations plans and survey of the literature. Revision of the standard on clinical investigations.


Originator: CEN

P member

CEN/TC 285

Non-active surgical implants


Originator: CEN
P member

CEN/TC 285

Non-active surgical implants

To standardize non-active surgical implants, including implant materials but not including dental implants and ophthalmic implants and, where appropriate, associated instrumentation to satisfy at least the essential requirements of the European Directive on Medical Devices, taking into account the work of CEN, CENELEC and ISO Technical Committees.


Originator: CEN

P member

CEN/TC 293

Assistive products and accessibility


Originator: CEN
P member

CEN/TC 293

Assistive products and accessibility

Standardization in the field of assistive products and related services including interoperability/interface between assistive and mainstream products to achieve accessibility. Standardization addressing general accessibility aspects of mainstream products, e.g. packaging, instructions for use, information, service development processes, not excluding other fields.


Originator: CEN

P member

CEN/TC 316

Medical products utilizing cells, tissues and/or their derivatives


Originator: CEN
P member

CEN/TC 316

Medical products utilizing cells, tissues and/or their derivatives

Development of European Standards for medical products manufactured utilizing animal and/or human tissues, cells and/or their derivatives, and related production technologies


Originator: CEN

P member

CEN/SS S02

Transfusion equipment


Originator: CEN
P member

CEN/SS S02

Transfusion equipment


Originator: CEN

P member

CEN/SS S99

Health, environment and medical equipment - Undetermined


Originator: CEN
P member

CEN/SS S99

Health, environment and medical equipment - Undetermined


Originator: CEN

P member

CEN/SS S03

Syringes


Originator: CEN
P member

CEN/SS S03

Syringes


Originator: CEN

P member

CEN/CLC/JTC 16

CEN/CENELEC Joint Technical Committee on Active Implantable Medical Devices


Originator: CEN
P member

CEN/CLC/JTC 16

CEN/CENELEC Joint Technical Committee on Active Implantable Medical Devices

To standardize all active implantable medical devices and their accessories


Originator: CEN

P member

CEN/CLC/JTC 3

Quality management and corresponding general aspects for medical devices


Originator: CEN
P member

CEN/CLC/JTC 3

Quality management and corresponding general aspects for medical devices

The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.


Originator: CEN

P member

CLC/TC 62

Electrical equipment in medical practice


Originator: CENELEC
P member

CLC/TC 62

Electrical equipment in medical practice

To establish harmonized standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment. NOTE: This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living).


Originator: CENELEC

P member

CEN/CLC/JTC 3

Quality management and corresponding general aspects for medical devices


Originator: CENELEC
P member

CEN/CLC/JTC 3

Quality management and corresponding general aspects for medical devices

The objective of the joint Technical Committee is to contribute to, and where necessary draft, suitable standards for "Quality management and corresponding general aspects for medical devices" that are applicable internationally and relevant to the essential requirements of EU Directives. The joint Technical Committee closely cooperates with ISO/TC 210 'Quality management and corresponding general aspects for medical devices' in the development of standards and revisions. The objective of the joint Technical Committee is to contribute to a further global harmonization of standards in close co-operation with ISO/TC 210. In principle the standards are drafted by ISO/TC 210 under the Vienna agreement with ISO-lead, including the joint work programme with IEC/SC 62. The joint Technical Committee will liaise with other Technical Committees - to achieve a coherent set of horizontal and product standards; - to minimize the necessity for additional European requirements; - to advise on aspects concerning quality management and risk management to ensure an optimal use of EN ISO 13485 and EN ISO 14971.


Originator: CENELEC

P member

CEN/CLC/JWG AIMD

CEN/CENELEC Joint Working Group on Active Implantable Medical Devices


Originator: CENELEC
P member

CEN/CLC/JWG AIMD

CEN/CENELEC Joint Working Group on Active Implantable Medical Devices

To standardize all active implantable medical devices and their accessories


Originator: CENELEC

P member

ISO/TC 76

Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use


Originator: ISO
O member

ISO/TC 76

Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

Standardization of containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.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.


Originator: ISO

O member

ISO/TC 84

Devices for administration of medicinal products and catheters


Originator: ISO
O member

ISO/TC 84

Devices for administration of medicinal products and catheters

Standardization of the performance of metered devices and supplies intended for administration of medicinal products, and standardization of syringes, needles and catheters. Excluded: non catheter devices intended for diagnostic use; anaesthetic and respiratory equipment, including lung ventilators and oxygen therapy devices, covered by ISO/TC 121; cartridge systems for dental use, covered by ISO/TC 106; specific requirements for components and devices, including prefilled syringes, covered by ISO/TC 76.


Originator: ISO

O member

ISO/TC 106

Dentistry


Originator: ISO
O member

ISO/TC 106

Dentistry

Standardization in oral health care including: terms and definitions; performance, safety, and specification requirements of dental products; andclinically relevant laboratory test methods, all of which contribute to improved global health.


Originator: ISO

O member

ISO/TC 121

Anaesthetic and respiratory equipment


Originator: ISO
O member

ISO/TC 121

Anaesthetic and respiratory equipment

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


Originator: ISO

O member

ISO/TC 150

Implants for surgery


Originator: ISO
O member

ISO/TC 150

Implants for surgery

Standardization in the field of implants for surgery 1) and their required instrumentation, covering terminology, specifications and methods of tests for all types of implants, and for the materials both basic and composite used in their manufacture and application. 1) Objects or devices which are surgically implanted in the body either temporarily or permanently for diagnostic or therapeutic purposes.


Originator: ISO

O member

ISO/TC 168

Prosthetics and orthotics


Originator: ISO
O member

ISO/TC 168

Prosthetics and orthotics

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).


Originator: ISO

O member

ISO/TC 170

Surgical instruments


Originator: ISO
O member

ISO/TC 170

Surgical instruments

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.


Originator: ISO

O member

ISO/TC 172

Optics and photonics


Originator: ISO
O member

ISO/TC 172

Optics and photonics

Standardization of terminology, requirements, interfaces and test methods in the field of optics and photonics. This includes complete systems, devices, instruments, ophthalmic optics, optical and photonic components, auxiliary devices and accessories, as well as materials. Optics and photonics are used in the meaning of generation, handling and detection of optical radiation including signal processing. Excluded : standardization for specific items in the field of cinematography (ISO / TC 36), photography (ISO / TC 42), eye protectors (ISO / TC 94), micrographics (ISO / TC 171), fibre optics for telecommunication (IEC / TC 86) and electrical safety of optical elements, and general lighting.


Originator: ISO

O member

ISO/TC 173

Assistive products


Originator: ISO
O member

ISO/TC 173

Assistive products

Standardization in the field of assistive products and related services to assist a person in compensating for reduced abilities. Excluded : assistive products that are dealt with by other technical committees and systems committees such as access to means of transport (ISO / TCs 8, 20, 22), building construction (ISO / TC 59), furniture (ISO / TC 136), implants for surgery (ISO / TC 150), prosthetics and orthotics (ISO / TC 168), optics and photonics(ISO / TC 172), electrical safety (IEC / TC 62), hearing aids (IEC / TC 29), ICT technologies (JTC1) and design principles dealt with by ergonomics (ISO/TC 159) and active assisted living (IEC SyCAAL).


Originator: ISO

O member

ISO/TC 194

Biological and clinical evaluation of medical devices


Originator: ISO
O member

ISO/TC 194

Biological and clinical evaluation of medical devices

Standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.


Originator: ISO

O member

ISO/TC 198

Sterilization of health care products


Originator: ISO
O member

ISO/TC 198

Sterilization of health care products

Standardization of processes and equipment for sterilization of health care products.


Originator: ISO

O member

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems


Originator: ISO
O member

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems

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).


Originator: ISO

O member

ISO/TC 227

Springs


Originator: ISO
O member

ISO/TC 227

Springs

Standardization in the field of metal springs covering exclusively product tolerances, terms and test methods, and process technology for springs (heat treatments, surface treatments, shot peening, etc.)Excluded : product specifications solely intended to cover each application, since some of them are currently in the scope of existing TC.


Originator: ISO

O member

ISO/TC 172/SC 1

Fundamental standards


Originator: ISO
O member

ISO/TC 172/SC 1

Fundamental standards


Originator: ISO

O member

TC 62/SC 62A

Common aspects of electrical equipment used in medical practice


Originator: IEC
O member

TC 62/SC 62A

Common aspects of electrical equipment used in medical practice

To prepare international standards concerning the common aspects of the manufacture, installation and application of electrical equipment used in medical practice, including systems, equipment, accessories, related terminology, concepts, terms, definitions and symbols.


Originator: IEC

O member

TC 62/SC 62B

Diagnostic imaging equipment


Originator: IEC
O member

TC 62/SC 62B

Diagnostic imaging equipment

To prepare international publications for safety and performance for all kind of medical diagnostic imaging equipment (e.g. X-ray imaging equipment, computed tomography, magnetic resonance imaging equipment) including related associated equipment and accessories as well as quality procedures (e.g. acceptance tests and constancy tests) to be applied during the life-time of imaging equipment. Included is also the development of related terminology, concepts, terms and definitions.


Originator: IEC

O member

TC 62/SC 62C

Equipment for radiotherapy, nuclear medicine and radiation dosimetry


Originator: IEC
O member

TC 62/SC 62C

Equipment for radiotherapy, nuclear medicine and radiation dosimetry

The preparation of standards for the safety and performance of medical equipment and systems using ionising radiation for the treatment of disease; associated equipment and software used in planning, delivering and monitoring such treatments; instruments measuring ionising radiation used in the diagnosis and treatment of disease as well as radiation conditions for testing them; and nuclear medicine equipment used for imaging the distribution of radioactive substances within the human body for both diagnostic purposes and radionuclide therapies.


Originator: IEC

O member

TC 62/SC 62D

Electromedical equipment


Originator: IEC
O member

TC 62/SC 62D

Electromedical equipment

To develop particular international standards and technical reports for electrical equipment used in medical practice. These documents cover the safety and/or performance of the equipment as well as related terminology, concepts, definitions and symbols.<br /> <br /> Note. Examples of the types of equipment covered by the scope of SC 62D include equipment used to diagnose patients, equipment used to monitor patients, and equipment used to treat or as an aid in the treatment of patients. Exclusions: Medical diagnostic imaging and related equipment (see scope of SC 62B) and medical equipment using high-energy ionizing radiation in therapy (see scope of SC 62C) are excluded.


Originator: IEC

O member

TC 62

Electrical equipment in medical practice


Originator: IEC
O member

TC 62

Electrical equipment in medical practice

To prepare international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment.<br /> <br /> NOTE : This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living).


Originator: IEC

O member

CEN/CLC/JWG AIMD

CEN/CENELEC Joint Working Group on Active Implantable Medical Devices


Originator: CEN
P member

CEN/CLC/JWG AIMD

CEN/CENELEC Joint Working Group on Active Implantable Medical Devices

To standardize all active implantable medical devices and their accessories


Originator: CEN

P member