BAS/TC 25 Tehnologija zaštite zdravlja

Oznaka: BAS/TC 25
Status: Aktivan
Predsjednik: Azra Ibrahimagić
Tehnički sekretar/koordinator: Tatjana Vidović

Naslov

Tehnologija zaštite zdravlja

Naslov na engleskom jeziku

Health protection technology

Područje rada

Priprema i utvrđivanje prijedloga bosanskohercegovačkih (BAS) standarda, preuzimanje međunarodnih i evropskih standarda, te revizija postojećih važećih standarda čije područje rada obuhvata standardizaciju terminologije, zahtjeva, specifikacija i ispitnih metoda u zdravstvenim strukama (farmacija, medicina, stomatologija i veterinarska medicina), uključujući tehničke uređaje, različite materijale, opremu, instrumente i sisteme neophodne za dijagnostiku i terapiju kao što su: anesteziološka, respiratorna i reanimaciona oprema, radiografska oprema, medicinska vozila i njihova oprema, transfuziona, infuziona i injekciona oprema, implantati za hirurgiju, hirurški instrumenti, pomoćna sredstva za invalidne i hendikepirane osobe, oftalmološka oprema i implantati, optika i optički instrumenti, laseri i pridružena oprema, lijekovi, biološka evalvacija medicinskih sredstava, klinička laboratorijska ispitivanja, in vitro dijagnostički sistemi ispitivanja i medicinska sredstva, mehanička kontraceptivna sredstva, električna oprema u medicinskoj praksi, kao i praćenje kvaliteta medicinskih sredstava i opreme prema zahtjevima i vodičima za praćenje kvaliteta.

Scope

Preparing and establishing proposals of B&H (BAS) standards, adopting international and European standards and the revision of existing valid standards related to standardization of terminology, requirements, specification and test methods in health professions (pharmacy, medicine, dentistry and veterinary medicine) including technical devices, different materials, equipment and systems necessary for the diagnosis and treatment(therapy) such as anesthetics, respiratory and reanimation equipment, radiographic equipment, medical vehicles and their equipment, transfusion, infusion and injection equipment, implants for surgery, surgical instruments, assistive products for persons with disability, ophthalmic equipment and implants, optics and optical instruments, lasers and related equipment, drugs, biological evaluation of medical devices, clinical laboratory tests, in vitro diagnostic test systems and medical devices, mechanical contraceptives, electrical equipment in medical practice, as well as monitoring the quality of medical devices and equipment according to requirements and guides for quality monitoring.

Veza sa svim međunarodnim/evropskim komitetima

CEN/TC 285

Non-active surgical implants

CEN/TC 293

Assistive products for persons with disability

TC 62/SC 62A

Common aspects of electrical equipment used in medical practice

TC 62/SC 62B

Diagnostic imaging equipment

TC 62/SC 62C

Equipment for radiotherapy, nuclear medicine and radiation dosimetry

TC 62/SC 62D

Electromedical equipment

CEN/TC 316

Medical products utilizing cells, tissues and/or their derivatives

CEN/TC 347

Methods for analysis of allergens

CEN/TC 55

Dentistry

ISO/TC 106

Dentistry

ISO/TC 121

Anaesthetic and respiratory equipment

ISO/TC 150

Implants for surgery

ISO/TC 157

Non-systemic contraceptives and STI barrier prophylactics

ISO/TC 168

Prosthetics and orthotics

ISO/TC 170

Surgical instruments

ISO/TC 172

Optics and photonics

ISO/TC 173

Assistive products for persons with disability

ISO/TC 194

Biological and clinical evaluation of medical devices

ISO/TC 198

Sterilization of health care products

CLC/TC 62

Electrical equipment in medical practice

TC 62

Electrical equipment in medical practice

CEN/CLC/JTC 3

Quality management and corresponding general aspects for medical devices

CEN/TC 123

Lasers and photonics

CEN/TC 204

Sterilization of medical devices

CEN/TC 205

Non-active medical devices

CEN/TC 206

Biological and clinical evaluation of medical devices

CEN/TC 215

Respiratory and anaesthetic equipment

CEN/TC 239

Rescue systems

CEN/TC 258

Clinical investigation of medical devices

ISO/TC 210

Quality management and corresponding general aspects for medical devices

ISO/TC 212

Clinical laboratory testing and in vitro diagnostic test systems

ISO/TC 76

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

ISO/TC 84

Devices for administration of medicinal products and catheters

CEN/TC 140

In vitro diagnostic medical devices

CEN/TC 170

Ophthalmic optics

CEN/SS S02

Transfusion equipment

CEN/SS S03

Syringes

ISO/TC 106/SC 1

Filling and restorative materials

ISO/TC 106/SC 2

Prosthodontic materials

ISO/TC 106/SC 3

Terminology

ISO/TC 106/SC 4

Dental instruments

ISO/TC 106/SC 6

Dental equipment

ISO/TC 106/SC 8

Dental implants

ISO/TC 121/SC 1

Breathing attachments and anaesthetic machines

ISO/TC 121/SC 2

Airways and related equipment

ISO/TC 121/SC 3

Lung ventilators and related equipment

ISO/TC 121/SC 4

Terminology and semantics

ISO/TC 121/SC 6

Medical gas systems

ISO/TC 121/SC 8

Suction devices for hospital and emergency care use

ISO/TC 150/SC 1

Materials

ISO/TC 150/SC 2

Cardiovascular implants and extracorporeal systems

ISO/TC 150/SC 4

Bone and joint replacements

ISO/TC 150/SC 5

Osteosynthesis and spinal devices

ISO/TC 172/SC 6

Geodetic and surveying instruments

ISO/TC 172/SC 7

Ophthalmic optics and instruments

ISO/TC 172/SC 9

Laser and electro-optical systems

ISO/TC 173/SC 1

Wheelchairs

ISO/TC 173/SC 2

Classification and terminology

ISO/TC 194/SC 1

Tissue product safety

CEN/CLC/JWG AIMD

CEN/CENELEC Joint Working Group on Active Implantable Medical Devices

CEN/TC 359

Hyperbaric chambers

CEN/TC 257

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

ISO/TC 173/SC 3

Aids for ostomy and incontinence

ISO/TC 106/SC 7

Oral care products

CLC/SR 56

Dependability

CLC/SR 29

Electroacoustics

ISO/TC 85/SC 2

Radiological protection

CEN/TC 352

Nanotechnologies

CEN/TC 352/WG 1

Measurement, characterization and performance evaluation

CEN/TC 352/WG 2

Commercial and other stakeholder aspects

CEN/TC 352/WG 3

Health, safety and environmental aspects

ISO/TC 229

Nanotechnologies

ISO/TC 229/CAG

Chairman Advisory Group

ISO/TC 229/JWG 1

Terminology and nomenclature

ISO/TC 229/JWG 2

Measurement and characterization

ISO/TC 229/TG 2

Consumer and societal dimensions of nanotechnologies

ISO/TC 229/WG 3

Health, Safety and Environmental Aspects of Nanotechnologies

ISO/TC 229/WG 4

Material specifications

ISO/TC 229/WG 5

Products and Applications