GSO ASTM F3108:2022
Gulf Standard
Current Edition
·
Approved on
12 May 2022
·
Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
GSO ASTM F3108:2022 Files
No files are available for this standard right now!
You can buy this standard from any member store
GSO ASTM F3108:2022 Scope
1.1 This guide is intended as a resource for individuals and
organizations when designing clinical trials and/or clinical
registries and addresses the selection of patient-reported
outcomes, safety outcomes, imaging outcomes and other topics
related to knee reconstructive surgery (KRS) including: (1)
knee replacement systems, (2) anterior cruciate ligament
reconstruction, (3) knee meniscus implants or tissue engineered medical products (TEMPs), (4) articular cartilage implants or TEMPS, (5) peri-articular knee osteotomies, (6)
peri-articular knee fractures (including distal femur, patella,
and proximal tibia fractures), or other knee surgeries.
1.2 In this guide, methods to measure the efficacy,
effectiveness, and safety of KRS devices through standardizing
clinical outcome measures are provided for designing,
reviewing, and accepting human clinical trial protocols.
1.3 This guide is intended to provide consistency in study
design, review, regulatory approval, and health insurance
coverage approval for knee reconstructive surgery to the health
care market.
1.4 For the purpose of this guide, KRS pertains to any
device or TEMP that is intended to replace, resurface,
reconstruct, and/or provide fixation of the knee joint, in part or
in total, as a treatment for joint disease, trauma, or dysfunction,
where long-term improvement in function and pain relief
without major adverse events are the desired outcomes.
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2302:2022
Gulf Standard
Cosmetic Products – Face Masks
GSO 1223:2023
Gulf Standard
Cosmetic Products-Deodorants
Recently Published from Health Sector
GSO ISO 17069:2024
ISO 17069:2020
Gulf Standard
Accessible design — Consideration and assistive products for accessible meeting
GSO ISO 11978:2024
ISO 11978:2017
Gulf Standard
Ophthalmic optics — Contact lenses and contact lens care products — Labelling
GSO ISO 16256:2024
ISO 16256:2021
Gulf Standard
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GSO ISO 14708-3:2024
ISO 14708-3:2017
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators