EN 1639-2009 pdf download.Dentistry-Medical devices for dentistry-Instruments.
3.3
hand-operated dental instrument
dental instrument designed to function in response to the operators manual movement without any other power source
4 Requirements
4.1 General
4.1.1 Dental instruments shall comply with the requirements which are applicable to them bearing in mind the intended purpose of the instrument concerned. Conformity with these requirements shall be considered to be met by demonstrating compliance with the requirements of the following subclauses, if appropriate.
4.1.2 For instruments intended to be used in connection with items of dental equipment, this standard and EN 1640 shall apply.
4.1.3 Dental instruments used in accordance with the instructions for use shall be safe for their intended purpose in the practice of dentistry.
4.1.4 Risk management shall be carried out and documented. This shall Include a risk analysis in accordance with EN ISO 14971.
4.2 Chemical and physical properties
4.2.1 General
4.2.1.1 MaterIal properties
Dental instruments shall comply with the material requirements as specified in the following standards, if appropriate:
EN ISO 1797-1. EN ISO 1797-2, EN ISO 3630-1, EN ISO 3630-2, EN ISO 3630-3. EN ISO 3823-1,
EN ISO 3823-2, EN ISO 7153-1, EN ISO 7492, EN ISO 7711-1, EN ISO 7711-2, EN ISO 771 1-3, EN ISO 7785-1,
EN ISO 7785-2, EN ISO 7885, EN ISO 9173-1, EN ISO 9873, EN ISO 9997, EN ISO 13295, EN ISO 13397-1,
EN ISO 13402, EN ISO 15087-1. EN ISO 15098-1, EN ISO 15606, EN 15021671.
4.2.1.2 Physical properties
Dental instruments shall comply with the physical properties (for example strength, bending and torque) as specified In the following standards, if appropriate:
EN 23964, EN 29168, EN ISO 1797-1, EN ISO 1797-2, EN ISO 3630-1, EN ISO 3630-2, EN ISO 3630-3,
EN ISO 3823-1, EN ISO 3823-2, EN ISO 7492, EN ISO 7711-1, EN ISO 7711-2. EN ISO 7711-3, EN ISO 7785-1,
EN ISO 7785-2. EN ISO 7885, EN ISO 9173-1, EN ISO 9873, EN ISO 9997, EN ISO 10323, EN ISO 13295,
EN ISO 13397-1. EN ISO 13397-2, EN ISO 13397-3, EN ISO 13397-4, EN ISO 15087-1. EN ISO 15087-2,
EN ISO 15087-3, EN ISO 15087-4, EN ISO 15087-5, EN ISO 15087-6, EN ISO 15098-1, EN ISO 15098-2,
EN ISO 15098-3, EN ISO 15606, EN ISO 21533, EN ISO 21671.
Test methods for dental rotary instruments for diameter. length, run-out and other requirements are specified in
EN ISO 8325.
42.2 Contaminants and residues
Dental instruments shall be designed and manufactured so that the transfer of contaminants and residues does not compromise the clinical condition or the safety of patients, or the safety and health of users. Design specifications are given in the product standards, The following standards shall apply, if appropriate:
EN 29168, EN ISO 3630-1, EN ISO 3630-2, EN ISO 3630-3, EN ISO 7785-1, EN ISO 7785-2, EN ISO 7885, EN ISO 9173-1, EN ISO 9873, EN ISO 9997, EN ISO 13397-1, EN ISO 13397-2, EN ISO 13397-3,
EN 1639:2009 (E)
EN ISO 13397-4. EN ISO 15087-1, EN ISO 15087-2, EN ISO 15087-3. EN ISO 15087-4. EN ISO 15087-5, EN ISO 15087-6. EN ISO 15098-1, EN ISO 15098-2, EN ISO 15098-3, EN ISO 15606, EN ISO 21533, EN ISO 21671.
4.2.3 Contact with substances
Dental instruments shall satisfy the performance requirements for safe use with substances with which they come into contact during normal use. The following standards shall apply, if appropriate:
EN ISO 7785-1, EN ISO 7785-2. EN ISO 7885, EN ISO 15606, EN 29168.
4.3 Control of contamination
4.3.1 General
4.3.1.1 Dental instruments shall be designed and manufactured so as to facilitate infection control.
4.3.1.2 If dental instruments are provided both in sterile and non-sterile conditions the condition in which they are supplied shall be clearly indicated.
4.3.1.3 Reusable dental instruments shall be capable of being reprocessed. For reprocessing of dental instruments EN ISO 17664 shall apply.
4.3.2 Instruments supplied sterile
4.3.2.1 Dental instruments supplied sterile shall comply with EN 556-1.
4.3.2.2 Sterilization processes shall be validated and regularly checked:
a) If dental instruments are to be sterilized by ethylene oxide. EN ISO 11135-1 shall apply:
b) If dental instruments are to be sterilized by irradiation, EN ISO 11137-1 shall apply;
c) If dental instruments are to be sterilized by moist heat, EN ISO 17665-1 shall apply.
4.3.2.3 Packaging systems for dental instruments supplied sterile shall be such that the instruments remain sterile until the package is opened before the expiry date. The product standards for the packaging systems shall be complied with, if appropriate.
Packaging systems for dental instruments supplied sterile shall be in accordance with EN ISO 11607-1 and
EN ISO 11607-2.
4.3.3 Instruments supplied non-sterile
4.3.3.1 Product-related risks of contamination to the patient and the dental personnel shall be reduced by
specific reprocessing methods given in the following standards, if appropriate:
EN 13060, EN ISO 3630-1, EN ISO 7785-1, EN ISO 7785-2, EN ISO 9173-1, EN ISO 9873, EN ISO 9997, EN ISO
13397-1, EN ISO 13402, EN ISO 15883-1, EN ISO 15087-1, EN ISO 15098-1, EN ISO 15606.
4.3.3.2 Packaging systems for dental instruments supplied non-sterile shall maintain the level of cleanliness of the instruments during transport and storage. The product standards for the packaging systems shall be complied with, if appropriate.
4.4 Construction and environmental properties
4.4.1 Dental instruments shall be designed and manufactured so that their physical and dimensional characteristics are suitable for their intended use and their use in combination according to the instructions for use.EN 1639-2009 pdf download.

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