ASTM F1638-95(2023) PDF

Name: ASTM F1638-95(2023) — Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)
SKU: ASTM F1638-95(2023)
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Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

Название (английский):

ASTM F1638-95(2023)

Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 2
Дата публикации:: 1 февраля 2023 г.
Издание:: F1638
ICS:: 01.040.11

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Описание (английский):

SCOPE 1.1 This terminology defines basic terms and considerations for components of thumb-type surgical forceps. Instruments with this terminology are limited to those fabricated from stainless steel and used for surgical procedures. 1.2 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.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ASTM

Overview

ASTM F1638-95(2023): Standard Terminology for Surgical Tissue/Dressing/Pick-Up Forceps (Thumb-Type) defines the essential terminology and considerations for thumb-type surgical forceps. Developed by ASTM International, this standard is crucial for ensuring consistency, clarity, and safety in the design and manufacture of stainless steel forceps used during surgical procedures worldwide. By adhering to internationally recognized standardization principles established by the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Committee, ASTM F1638 provides a common language for manufacturers, healthcare providers, and regulatory authorities.

Key Topics

Standardized Terms: The document explicitly defines basic and advanced terminology, including component names and features relevant to thumb-type surgical forceps. Examples include guide pin, mesh, mouse teeth, scissoring, set, stop pin, atraumatic teeth, and tissue forceps.

Component Descriptions:

Guide pin: A pin on one half of the forceps that aligns with a hole on the other half for precision closure.
Mesh: Alignment of opposing teeth-can be in-line or angled-to ensure precise gripping.
Mouse teeth: Interdigitated teeth at the distal tip for secure tissue handling.
Atraumatic: Design of teeth that minimizes tissue trauma during use.

Material Limitation: This terminology applies specifically to forceps fabricated from stainless steel, reflecting common clinical requirements for sterility, corrosion resistance, and strength.

Design Considerations: The standard recognizes the clinical need for diverse instrument configurations and features, without limiting technological innovation or future enhancements in forceps design.

Applications

Surgical Practices: Used by surgeons and clinicians to describe, select, and use thumb-type forceps in various procedures, reducing ambiguity in instrument handling.

Manufacturing: Medical device manufacturers utilize ASTM F1638 terminology to standardize product descriptions, quality control processes, and compliance documentation, facilitating clearer communication and interoperability between suppliers and healthcare providers.

Regulatory Compliance: Adoption of standardized terminology aids in meeting regulatory requirements for medical device registration, import/export, and clinical application, especially for global markets that recognize WTO principles.

Procurement and Training: Hospitals and clinical training programs benefit from unified terms, supporting effective procurement, inventory management, and staff training regarding surgical tissue forceps.

Related Standards

ASTM F899: Standard Specification for Stainless Steels for Surgical Instruments – Covers material requirements relevant to instruments defined in ASTM F1638.

ISO 7153-1: Surgical Instruments - Materials – International standard overlapping with ASTM F1638 in specifying acceptable materials for surgical forceps.

ASTM F1744: Standard Guide for Care and Handling of Stainless Steel Surgical Instruments – Complements the terminology by providing guidelines for instrument maintenance.

ISO 13485: Medical Devices – Quality Management Systems – Supports manufacturers in establishing processes to consistently meet customer and regulatory requirements for surgical instruments.

ASTM Committee F04: Oversight body for standards on medical and surgical materials, including those directly relevant to surgical forceps.

By providing clear terminology and focusing on best practices for thumb-type surgical forceps, ASTM F1638-95(2023) enhances safety, communication, and innovation across the global healthcare industry.

ASTM F1638-95(2023) PDF

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

SIST EN ISO 7153-1:2017

Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)

SIST EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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