ISO 9714-1:2012

Orthopaedic drilling instruments - Part 1: Drill bits, taps and countersink cutters

ISO 9714-1:2012 specifies materials and mechanical properties, dimension and marking requirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws specified in ISO 5835.

Instruments de forage orthopédiques — Partie 1: Tarauds, forets et fraises à lamer

General Information

• Status: Published
• Publication Date: 30-May-2012
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Drafting Committee: ISO/TC 150/SC 5 - Osteosynthesis and spinal devices
• Current Stage: 9093 - International Standard confirmed
• Start Date: 15-May-2023
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO 9714-1:1991 - Orthopaedic drilling instruments - Part 1: Drill bits, taps and countersink cutters
• Effective Date: 24-Oct-2009

Overview

ISO 9714-1:2012 - Orthopaedic drilling instruments - Part 1: Drill bits, taps and countersink cutters - specifies requirements for stainless-steel drill bits, taps and countersink cutters intended for orthopaedic surgery used with bone screws specified in ISO 5835. The standard covers permitted materials and mechanical properties, dimensional limits and marking/identification requirements to ensure compatibility and interchangeability of tools and implants. (Second edition, replaces ISO 9714-1:1991.) Note: it does not apply to self-drilling pins or self-drilling guide pins.

Key topics and technical requirements

• Material specifications
  • Acceptable stainless steel grades are listed (austenitic and martensitic types) with chemical-composition references drawn from ISO 7153‑1, EN 10088 and ASTM F899.
  • Materials and mechanical-property requirements govern suitability for surgical use.
• Dimensions and geometry
  • Drill bit diameters and permitted tolerances are specified (see Table 2 in the standard).
  • Drill point angle requirement: (90 ± 10)°.
  • Taps: core and outside diameters follow the dimensions in Table 2; thread form and pitch must match the corresponding bone screw per ISO 5835.
  • Countersink cutters: pin and cutter-head diameters as per Table 2; cutter head may be conical (90 ± 2)° or spherical.
• Marking and identification
  • Drill bits: must be marked with diameter in millimetres.
  • Taps: marked with the ISO 5835 screw code and nominal size for which they are intended.
  • Countersink cutters: marked with nominal screw sizes per ISO 5835.
• Interrelationships
  • Annex A illustrates the relationship between bone screws, plates and relevant tools to promote compatibility across the series of orthopaedic standards.

Practical applications and users

ISO 9714-1:2012 is intended for:

• Medical device manufacturers producing orthopaedic drill bits, taps and countersink cutters to ensure conformity, interchangeability and safe clinical use.
• Design and quality engineers validating material selections, dimensions and marking procedures for instrument production.
• Regulatory and procurement teams requiring standards-based specifications for instrument acceptance and supplier evaluation.
• Clinical engineers / hospital sterile services for tool identification and inventory compatibility with ISO 5835 bone screws.

Using this standard helps reduce risk of mismatched tools, supports regulatory compliance, and facilitates international trade and compatibility of orthopaedic instrumentation.

Related standards

• ISO 5835 - Metal bone screws (used for screw-tool compatibility)
• ISO 7153-1, EN 10088-3, ASTM F899 - Stainless steel material references
• Other related ISO standards on implants, drive connections and plates (listed in the ISO 9714-1 bibliography)

Keywords: ISO 9714-1:2012, orthopaedic drilling instruments, drill bits, taps, countersink cutters, stainless steel, ISO 5835, dimensions, marking, surgical instruments.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 9714-1
Second edition
2012-06-01
Orthopaedic drilling instruments —
Part 1:
Drill bits, taps and countersink cutters
Instruments de forage orthopédiques —
Partie 1: Tarauds, forets et fraises à lamer
Reference number
©
ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2012 – All rights reserved

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 9714-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5,
Osteosynthesis and spinal devices.
This second edition cancels and replaces the first edition (ISO 9714-1:1991), which has been technically revised.
ISO 9714 consists of the following parts, under the general title Orthopaedic drilling instruments:
— Part 1: Drill bits, taps and countersink cutters
INTERNATIONAL STANDARD ISO 9714-1:2012(E)
Orthopaedic drilling instruments —
Part 1:
Drill bits, taps and countersink cutters
1 Scope
This part of ISO 9714 specifies materials and mechanical properties, and dimension and marking requirements
for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone
screws specified in ISO 5835.
NOTE The interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is
shown in Annex A.
This part of ISO 9714 is not applicable to self-drilling pins, such as those used in external fixation, and self-
drilling guide pins.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 5835:1991, Implants for surgery — Metal bone screws with hexagonal drive connection, spherical under-
surface of head, asymmetrical thread — Dimensions
3 Materials and dimensions
3.1 Material
Drill bits, taps and countersink cutters may be made from metal complying with the requirements given in Table 1.
2 © ISO 2012 – All rights reserved
Table 1 — Steel grades and chemical compositions
a
Steel grade in accordance with: Chemical composition %
ISO 7153-1:
EN 10088- ASTM C Si Mn P Other
b
1991 ref. AISI S Cr Mo Ni
3: 2005 F899: 2011 max. max. max. max. elements
letter
Austenitic stainless steels
M 1.4301 304 304 0,07 1 2 0,045 0,03 max. 17 to 19 – 8 to 11 N: 0,10 max.
c
N – 303 303 0,12 1 2 0,06 0,15 to 0,35 17 to 19 0,7 max. 8 to 10 –
O 1.4310 301 301 0,15 1 2 0,045 0,03 max. 16 to 18 – 6 to 8 –
P 1.4408 316 316 0,07 1 2 0,045 0,03 max. 16,5 to 18,5 2 to 2,5 10,5 to 13,5 N: 0,10 max.
– 1.4404 or 316L – 0,03 1 2 0,045 0,03 max. 16 to 19 2,0 to 3 10,0 to 15 –
1.4435
Martensitic steels
– – – 420A 0,16 to 0,25 1 1 0,04 0,03 max. 12 to 14 – 1 max. –
– – – 420B 0,26 to 0,35 1 1 0,04 0,03 max. 12 to 14 – 1 max. –
D – 420C 420C 0,42 to 0,50 1 1 0,04 0,03 max. 12,5 to 14,5 – 1 max. –
H – – 0,35 to 0,4 1 1 0,045 0,03 max. 14 to 15 0,4 to 0,6 – V: 0,1 to
0,15
I – – 0,42 to 0,55 1 1 0,045 0,03 max. 12 to 15 0,45 to 0,90 – V: 0,1 to
0,15
R 1.4112 440B 0,85 to 0,95 1 1 0,045 0,03 max. 17 to 19 0,9 to 1,3 – V: 0,07 to
0,12
– – – 440B 0,75 to 0,95 1 0,04 0,03 max. 16 to 18 0,75 max. – –
S 440A 440A 0,60 to 0,75 1 1 0,040 0,03 max. 16 to 18 0,75 max. – –
a
Chemic
...