BAS/TC 25

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Opšte informacije

Status:

Aktivan

Predsjednik:

Erna Skenderović

Tehnički sekretar/koordinator:

Tatjana Vidović

E-mail:

tatjana.vidovic@isbih.gov.ba

Korisni linkovi

Plan rada BAS/TC 25 Usvojeni standardi Poslovni plan

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.

Veza sa međunarodnim/evropskim komitetima

CEN/TC 285

Non-active surgical implants

CEN/TC 293

Assistive products and accessibility

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

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

Respiratory devices and related equipment used for patient care

ISO/TC 121/SC 4

Vocabulary and semantics

ISO/TC 121/SC 6

Medical gas supply systems

ISO/TC 121/SC 8

Suction devices

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

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 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

Sustainability, 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

TC 113

Nanotechnology for electrotechnical products and systems

CEN/TC 362

Healthcare services - Quality management systems

CEN/TC 367

Breath-alcohol testers

CEN/TC 403

Aesthetic surgery and aesthetic non-surgical medical services

CEN/SS S99

Health, environment and medical equipment - Undetermined

CLC/SR 113

Nanotechnology standardization for electrical and electronics products and systems

TC 29

Electroacoustics

CEN/TC 102

Sterilizers and associated equipment for processing of medical devices

CEN/CLC/JTC 16

Active Implantable Medical Devices

ISO/TC 304

Healthcare organization management