EN ISO 3630-1:1994

Dental root-canal instruments - Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches (ISO 3630-1:1992)

Zahnärztliche Wurzelkanalinstrumente - Teil 1: Wurzelkanalfeilen, Reibahlen, Nervnadeln, Raspeln, Wurzelfüller, Sonden und Wattenadeln (ISO 3630-1:1992)

Instruments pour canaux radiculaires utilisés en art dentaire - Partie 1: Limes, alésoirs, broches barbelées, râpes, bourre-pâtes, sondes exploratrices et broches porte-coton (ISO 3630-1:1992)

Dental root-canal instruments - Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches (ISO 3630-1:1992)

General Information

• Status: Withdrawn
• Publication Date: 17-Oct-1994
• Withdrawal Date: 31-Jan-2008
• ICS: 11.060.20 - Dental equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Feb-2008
• Completion Date: 01-Feb-2008
• Ref Project: SIST EN ISO 3630-1:2000 - Dental root-canal instruments - Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches (ISO 3630-1:1992)

Relations

• Parent: EN 23630-2:1991 - Dental root canal instruments - Part 2: Enlargers (ISO 3630-2:1986)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 3630-1:2008 - Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3630-1:2000
01-januar-2000
Dental root-canal instruments - Part 1: Files, reamers, barbed broaches, rasps,
paste carriers, explorers and cotton broaches (ISO 3630-1:1992)
Dental root-canal instruments - Part 1: Files, reamers, barbed broaches, rasps, paste
carriers, explorers and cotton broaches (ISO 3630-1:1992)
Zahnärztliche Wurzelkanalinstrumente - Teil 1: Wurzelkanalfeilen, Reibahlen,
Nervnadeln, Raspeln, Wurzelfüller, Sonden und Wattenadeln (ISO 3630-1:1992)
Instruments pour canaux radiculaires utilisés en art dentaire - Partie 1: Limes, alésoirs,
broches barbelées, râpes, bourre-pâtes, sondes exploratrices et broches porte-coton
(ISO 3630-1:1992)
Ta slovenski standard je istoveten z: EN ISO 3630-1:1994
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 3630-1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 3630-1:2000

---------------------- Page: 2 ----------------------

SIST EN ISO 3630-1:2000

---------------------- Page: 3 ----------------------

SIST EN ISO 3630-1:2000

---------------------- Page: 4 ----------------------

SIST EN ISO 3630-1:2000

---------------------- Page: 5 ----------------------

SIST EN ISO 3630-1:2000

---------------------- Page: 6 ----------------------

SIST EN ISO 3630-1:2000
ISO
INTERNATIONAL
36304
STANDARD
First edition
1992-12-15
Dental root-canal iinstruments -
Part 1:
Files, reamers, barbed broaches, rasps, Paste
carriers, explorers and cotton broaches
Instruments pour canaux radiculaires utilises en art dentaire -
Partie 1: Limes, aksoirs, broches barbelees, rapes, bourre-pates, sondes
exploratrices et broches porte-coton
-
---
---
----
~_--_
------.----
---- . ----~
--- ----
Reference number
--- ----- ISO 36304 : 1992( E)
--
_ _-- =--TT:z:~T---:

---------------------- Page: 7 ----------------------

SIST EN ISO 3630-1:2000
ISO 3630=1:1992(E)
Contents
Page
1
1 Scope .,.s. . . . . . . . . . . . . . . . . . . . . . . . .*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
. . . . . . . . . . . . . . . . . . . . . .~.
2 Normative references
3 Nominal sizes, designation (Code number) and corresponding
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
diameters
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4 Requirements
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Material
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
4.2 Dimensional requirements
IO
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 Mechanical requirements
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.4 Chemical requirements
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Sampling
12
6 Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
6.1 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
..~...........,.,,..........,....................
6,2 Measurement of dimensions
. . . . 12
6.3 Resistance to fracture in torque and angular deflection
13
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.4 Resistance to bending
. . . . . . . . . . . . . . . . . . . . 14
6.5 Resistance to pull and twist: handle or shank
14
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6 Resistance to corrosion
15
. . . . .*.
6.7 Heat effects of sterilization
............... .................. 15
7 Designation, marking and identification
15
. . . . . . . . . . .*.
7.1 Code for colour designation
16
. . . . . . . . . . . .~.~.
7.2 Additional designation
16
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3 Identification Symbols
17
..,.............................s........ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.......
8 Packaging
. . . . . . . . . . . . . . . . . . . . . . . . . 17
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9 Marking
0 ISO 1992
All rights reserved. No part of this publication may be reproduced or utilized in any form
or by any means, electronie or mechanical, including photocopying and microfilm, without
Permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii

---------------------- Page: 8 ----------------------

SIST EN ISO 3630-1:2000
ISO 36304 :1992(E)
Annex
A Bibliogt-aphy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
19
. . .
Ill

---------------------- Page: 9 ----------------------

SIST EN ISO 3630-1:2000
ISO 3630=1:1992(E)
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. Esch 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, govern-
mental and non-governmental, in liaison with ISO, also take patt in the
work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard ISO 3630-1 was prepared by Technical Committee
ISO/TC 106, Dentistry, Sub-Committee SC 4, Dental instruments.
This first edition of ISO 3630-1 cancels and replaces ISO 3630:1984, of
which it constitutes a technical revision.
ISO 3630 consists of the following Parts, under the general title Dental
root-canal insfruments:
broaches, rasps, Paste carriers,
- Part 1: Files, reamers, barbed
explorers and cotton broaches
- Part 2: Enlargers
- Part 3: Condensers, pluggers and spreaders
lt is anticipated that additional types of instruments will form the subject
of additional future Parts.
Annex A of this patt of ISO 3630 is for information only.

---------------------- Page: 10 ----------------------

SIST EN ISO 3630-1:2000
ISO 36304:1992(E)
Introduction
This International Standard covers significant features of hand- and
power-operated dental root canal instruments which are used by the
dentist for the mechanical preparation of root canals for treatment. In
dentistry these instruments are also referred to as endodontic instru-
ments.
Part 1, in addition to the specific instruments indicated, includes general
specifications, requirements and test methods which are applicable to
all types of root-canal instruments.
Attention is drawn to the International Standard on a number coding
System, ISO 6360, which specifies a 15-digit number for the identification
of dental rotary instruments of all types.
V

---------------------- Page: 11 ----------------------

SIST EN ISO 3630-1:2000
This page intentionally left blank

---------------------- Page: 12 ----------------------

SIST EN ISO 3630-1:2000
ISO 3630=1:1992(E)
INTERNATIONAL STANDARD
Dental root-canal instruments -
Part 1:
Files, reamers, barbed broaches, rasps, Paste carriers,
explorers and cotton broaches
1 Scope
This patt of ISO 3630 specifies requirements and test methods for files, reamers, barbed broaches, rasps, Paste
carriers, explorers and cotton broaches. In addition it covers general specifications, test methods, information
on the designation code and identification Symbols for root-canal instruments independent of specific types.
The requirements of this part of ISO 3630 shall become effective Zwo years from the date of publication.
2 Normative references
The following Standards contain provisions which, through reference in this text, constitute provisions of this
part of ISO 3630. At the time of publication, the editions indicated were valid. All Standards are subject to re-
Vision, and Parties to agreements based on this part of ISO 3630 are encouraged to investigate the possibility
of applying the most recent editions of the Standards indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
ISO 1797-1:1992, Dental rotary instruments - Shanks - Part 1: Shanks made of metals.
ISO 1797-2:1992, Dental rotary instruments - Shanks - Part 2: Shanks made of plastics.
- Specification and test methods.
ISO 3696:1987, Water for analytical laboratory use
ISO 6360-1:1985, Dental rotary instruments - Number coding System - Part 1: General characteristics.
ISO 6360-2:1986, Dental rotary instruments - Number coding System - Part 2: Shape and specific character-
istics.
ISO 8601:1988, Data elements and interchange formats - Information interchange - Representation of dates and
firnes.
1

---------------------- Page: 13 ----------------------

SIST EN ISO 3630-1:2000
ISO 36304 :1992(E)
3 Nominal sizes, designation (Code number) and corresponding diameters
Tabie 1 gives the nominal sizes for the working Parts to be used for all dental root-canal instruments regardless
of the type of instrument.
The nomina I sizes usually correspond to the values of the extended dia rs at the tip or the working part in
hun
dredths of a millimetre.
The designation (Code number) with three digits is par-t sf the 15-digit identification number laid down in
ISO 6360-1.
Table 1 - Nominall sizes, designation (Code
number) and corresponding diameters
Nominal size: designation Corresponding diameter
(Code number) mm
008 0,08
010 0,lO
012 0,12
015 0,15
017 0,17
020 0,20
025 0,25
030 0,30
035 0,35
040 0,40
045 0,45
050 0,50
055 0,55
060 0,60
070 0,70
075 0,75
080 0,80
090 0,90
100 1 ,oo
105 1,05
110 1,lO
120 1,20
130 1,30
140 1,40
150 1,50
160 1,60
1,70
170
190 1,90
4 Requirements
4.1 Material
4.1.1 Working part
The working part and the shaft, if one Part, shail be made of stainless steel or carbon steel. The type of steel
and the treatment shall be at the discretion of the manufacturer.

---------------------- Page: 14 ----------------------

SIST EN ISO 3630-1:2000
ISO 363001:1992(E)
4.1.2 Handle, shank
The handle, or shank, when affixed to the shaft, shall be made of metal or plastics material (see ISO 1797-1 and
ISO 1797-2 respectively) of a quality suitable to withstand normal operative procedures. The type of material
and the treatment shall be at the discretion of the manufacturer.
If the requirements of 4.2 to 4.4 are fulfilled, the instruments are considered also to comply with the require-
ments of 4.1.2.
4.2 Dimensional requirements
The dimensions are given in millimetres.
The dimensional requirements of the instruments shall comply with the respective tables and figures; within the
dimensional requirements, variations in shape and design are permitted.
Testing shall be carried out in accordance with 6.1 and 6.2.
4.2.1 Shanks
Shanks shall be type 1 or 2 as specified in ISO 1797-1. Instruments used with type 1 or 2 shanks shall be op-
erated with handpieces that are restricted to operate at slow Speed. Except for Paste carriers the handpieces
shall have only an action of pulling motion and/or reciprocating motion (90’ maximum) unless otherwise
specified.
4.2.2 Files and reamers
This clause covers the following types of instruments:
Files, type H
Files, type K
Reamers, type K
These files and reamers shall be in accordance with figure 1 and tables 2 to 4.
The dimensions are aligned with those of the dental obturating Points (see ISO 6877) and dental absorbent Points
NOTE 1
(see note 6).

---------------------- Page: 15 ----------------------

SIST EN ISO 3630-1:2000
ISO 36304 :1992(E)
r Handle
X
/
\
.’
I
,’
.
0
~-~-_-
0 -L
6
- o\
‘\
I
l
‘\
I
1) i
-( -
1, 3 O,Sd,
1, 4 0,87d,
The tip length shall be within thc limits specified by the minimal and maximal angle (I, min. to I, max.).
Shape and tip at the manufacturer’s discretion.
Handle or shank (type 1 or 2 of ISO 17974) at the manufacturer’s discretion.
Taper along working part 0,02:1
Detail Y: see table2
diameter of the projection of the working part at the tip end (
nominal size)
4
dz diameter at length Zz
(;E3 diameter at the end of minimum length of working Part, lengt
h *3
I, tip length
Zz length for measuring Point LI*
Z3 length for measuring Point d3 and minimum length of working part
length of operative end
24
Figure 1 - Files, type H: files, type K; reamers, type K

---------------------- Page: 16 ----------------------

SIST EN ISO 3630-1:2000
ISO 3630=1:1992(E)
Table 2 - Typical flute form, detail Y
Detail Y
Instrument
(see figure 1)
Files, type H
Files, type K
Reamers, type K
Table 3 - Dimensions and designation
Colour
di d2
d3 13
Nominal size
T
designation
ref. toi. toi. min.
008 0,08
0,14 0,40
W-Y
010 0,lO 0,16
0,42 purple
015 0,15 0,21 0,47 white
020 0,20 0,26 0,52 yellow
025 0,25 0,31 0,57 red
030
0,30 0,36 0,62 blue
035 0,41
0,35 + 0,02 0,67 + 0,02 green
- -
040 0,40 0,46 0,72 black
045 0,45 0,51 0,77 white
050 0,50 0,56 0,82
yellow
055 0,55 0,61 0,87 red
060 0,60 0,66 0,92 3 16 blue
070 0,70 0,76 1,02
green
080 0,80 0,86 1,12
black
-
090
0,90 0,96 1,22 white
100 1 ,oo 1,06 + 0,04
1,32 + 0,04 yellow
- -
110 1,lO 1,16 1,42
red
120 1,20 1,26 1,52
blue
130 1,30 1,36 1,62
green
140 1,40 1,46 1,72 black
Table 4 - Length 2’
*4
+ 0,5
-
21
25
28
31
NOTE - Lengths of instruments not listed shall be
within k 0,5 mm of the stated length.

---------------------- Page: 17 ----------------------

SIST EN ISO 3630-1:2000
ISO 36304:1992(E)
4.2.3 Barbed broaches
Barbed broaches shall be in accordance with figure2 and table5.
Shape of tip at the manufacturer’s Hand use: design of handle at the
discretion manufacturer’s discretion
diameter of the projection of the core at the tip end
4
diameter of core at length l2
d2
diameter of core at length Z3
4
h height of barb
length measured from tip Point to base of first barb
4
length for measuring Point d2
l2
length for measuring Point d3 and length of working part
23
length of operative end
24
Figure 2 - Barbed broaches
Table 5 - Dimensions and designation
-
~~
I
13 24 h Number Designation
Liz
Nominal
-- .
of bat-w c 2olour Number
sizel)
toi. toi.
toi. min. z min.
* 195
0,22
020 0,12 0,15 purple 0
0,075
* 0,02 0,17 -f- 0,02 0,24
025 0,14 It OP white 1
0,085
0,19 0,26
030 0,16 yellow 2
0,095
035 0,18 3 IO,5
20 0,105 36 red 3
040 0,21 4
0,120 blue
050 0,25
0,140 green 5
I I
060 0,29
0,160 black
I I I
1
I
1) The nominal size designation is calculated by the core diamater d, plus approximately twice the height of the barbs.

---------------------- Page: 18 ----------------------

SIST EN ISO 3630-1:2000
ISO 36304:1992(E)
4.2.4 Rasps
Rasps shall be in accordance with figure3 and table6.
Handle
r
Shape of tip and design of handle
at the manufacturer’s discretion
diameter of the projection of the core at the tip end
4
diameter of core at length Z2
d2
diameter of core at length Z3
d3
h height of barb
length measured from tip Point to base of first barb
4
length for measuring Point d2
22
length for measuring Point tzi3 and length of working part
*3
length of operative end
4
Figure 3 - Rasps
Table 6 - Dimensions and designation
-I-
Number
I l
of Designation
4 4 d3 *2
Nominal
barbs
size 1)
Colour Number
+ 0,03
+0,03 to,o3
min.
+ 13
0 0 0
0,05 white 1
025 0,15 0,20 0,31
030 0,18 0,23 0,34 0,06 yellow 2
035 0,21 0,26 0,37 0,07 red 3
50
3 10,5 25,5
4
040 0,24 0,29 0,40 0,08 blue
0,09 green 5
045 0,27 0,32 0,43
0,46 0,lO black 6
050 0,30 0,35
I
1) The nominal size designation is calculated by the core diameter d, plus approximately twice the height of the barbs.
7

---------------------- Page: 19 ----------------------

SIST EN ISO 3630-1:2000
ISO 3630=1:1992(E)
4.2.5 Paste carriers
Paste carriers shall be in accordance with figure4 and tables 7 and 8.
Shank type 1 or 2 in ISO 1797-1,
at the manufacturer’s discretion
Winding of spiral at the manufacturer’s discretion. The winding
...