ISO 8319-2:1986 PDF

Name: ISO 8319-2:1986 — Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
SKU: ISO 8319-2:1986
Price: 25 EUR
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Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws

Название (английский):

ISO 8319-2:1986

Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 9 октября 1986 г.
Издание:: ISO IS 8319 edition 1 version 1
ICS:: 11.040.40

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Цена:120 €

Описание (английский):

The purpose is to ensure that the essential requirements of all screw keys are achieved without imposing undue restriction on design features. This standard specifies the requirements for screwdrivers used in orthopaedic surgery for inserting and removing bone screws. Screw keys with the working end specified are suitable for use with screws which conform to ISO 9268.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 8319-2:1986 specifies requirements for screwdrivers used in orthopaedic surgery to insert and remove bone screws with single-slot heads, cruciate slots and cross-recessed (modified Phillips) heads. The standard focuses on drive connections and screwdriver bits - defining shapes, dimensions, materials, mechanical performance and marking - while avoiding undue restrictions on design. Screwdrivers covered are intended for use with bone screws that conform to ISO 9268.

Key topics and technical requirements

Design and dimensions

Defines bit geometries for hand and power-driven screwdrivers for single-slot, cruciate and cross-recessed heads.
Includes dimension tables and figures for bit shapes, flutes and recess profiles (see Table 1 and figures in the standard).

Materials and hardness

Blade materials specified include martensitic stainless steel (e.g., grades from ISO 683/13) and cold-worked cobalt‑chromium‑tungsten‑nickel alloys (ISO 5832/5).
Rockwell hardness ranges are given (e.g., stainless steel ~48–54 HRC; cobalt‑chromium alloys ~48–50 HRC).

Mechanical performance and testing

Torque and torsion testing procedures for blades, bits and complete screwdrivers are defined (including use of torque-testing dies).
The blade-to-handle connection must withstand specified test torques without loosening, fracture or permanent deformation (the text includes a test torque example of 9.7 N·m).
Slot/drive test discs and dimensional tolerances are specified in relation to ISO 2380 and related test methods.

Marking

Required permanent markings include intended screw size (code and thread diameter per ISO 9263), manufacturer name/trademark, ISO 8319 part number (if space) and material (if space).

Applications and users

Who uses ISO 8319-2

Medical device manufacturers that design and produce orthopaedic screwdrivers and driving tools.
Surgical instrument designers and quality engineers responsible for acceptance testing and compliance.
Hospitals, procurement and sterile services teams specifying compliant instruments for orthopaedic procedures.
Test laboratories that validate mechanical and material properties of surgical screwdrivers.

Practical value

Ensures interchangeability and reliable engagement between drive tools and bone screws.
Reduces risk of tool failure during surgery by specifying materials, hardness and torque resistance.
Supports regulatory compliance and consistent manufacturing quality.

Related standards

ISO 9268 (metal bone screws - dimensions)

ISO 2380 (screwdriver blades for slotted head screws)

ISO 683/13 (heat-treated and wrought stainless steels)

ISO 5832/5 (wrought cobalt‑chromium‑tungsten‑nickel alloy)

ISO 6508 / ISO 6568 (hardness and test methods)

ISO 9263 (screw size coding and marking)

Keywords: ISO 8319-2, orthopaedic instruments, drive connections, screwdrivers, bone screws, single-slot, cruciate, cross-recessed, surgical instruments, torque test, medical device standards.

ISO 8319-2:1986 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 9268:1988

Implants for surgery — Metal bone screws with conical under-surface of head — Dimensions

ISO 683-13:1974

Heat-treated steels, alloy steels and free-cutting steels — Part 13: Wrought stainless steels

ISO 5832-5:1993

Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel alloy

ISO 2380-2:2000

Assembly tools for screws and nuts — Screwdrivers for slotted-head screws — Part 2: General requirements, len…

ISO 83:1976

Steel — Charpy impact test (U-notch)

SIST EN ISO 6508-1:2024

Metallic materials - Rockwell hardness test - Part 1: Test method (ISO 6508-1:2023)

ISO 6568:1981

Natural gas — Simple analysis by gas chromatography