This part of GB 11239 specifies the technical requirements, test methods, inspection rules, marking, labeling, instructions for use, packaging, transportation and storage requirements of operation microscopes (excluding accessories such as photographic cameras).
This part is applicable to operation microscopes used for observation during microsurgery and treatment of patients.
This part is not applicable to the specific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery.
2 Normative references
The following normative documents contain provisions which, through reference of GB 11239, constitute provisions of this part. For dated references, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document applies.
GB/T 191-2000 Packaging - Pictorial marking for handling of goods (eqv ISO 780: 1997)
GB/T 2828.1-2003 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (apply to inspection of process stability)
GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety (GB 9706.1-2007, idt IEC 60601-1:1988)
GB/T 10050-1988 Optics and optical instruments - Reference wavelengths (eqv ISO 7944:1984)
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
JB/T 9328-1999 Resolving power test target
ISO 10526:1999 (E) CIE standard illuminants for colorimetry
3 Terms, definitions and classification
3.1 Terms and definitions
3.1.1
operation microscopes
stereomicroscope used for observation during surgical and other medical procedures, consisting of an optical system of observation, including objective lens, optical system with variable magnification, eyepiece tube and eyepieces as well as lighting system, stand and electrical device, with corresponding accessories configured according to different use requirements
3.1.2
working distance
working distance of operation microscopes may be classified into step working distance (focal length of large objective lens) or stepless working distance (automatic focusing of objective lens), with nominal values preferably calculated using Equation (1):
W=100+25n (1)
Where,
W——the working distance, mm;
n——an integer between 0 and 16.
3.2 Classification
Large objective lens operation microscope: a large objective lens is shared within the binocular optical path system of operation microscope; small objective lens operation microscope: the binocular optical path system of operation microscope is equipped with objective lens separately.
Foreword i 1 Scope 2 Normative references 3 Terms, definitions and classification 4 Requirements 5 Inspection rules 6 Test methods 7 Marking, labeling and instructions for use 8 Packaging, transportation and storage Annex A (Informative) Comparison between this part and ISO 10936.1: 2000 in clause/subclause number Annex B (Informative) Technical differences between this part and ISO 10936.1: 2000 and their causes
1 Scope
This part of GB 11239 specifies the technical requirements, test methods, inspection rules, marking, labeling, instructions for use, packaging, transportation and storage requirements of operation microscopes (excluding accessories such as photographic cameras).
This part is applicable to operation microscopes used for observation during microsurgery and treatment of patients.
This part is not applicable to the specific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery.
2 Normative references
The following normative documents contain provisions which, through reference of GB 11239, constitute provisions of this part. For dated references, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document applies.
GB/T 191-2000 Packaging - Pictorial marking for handling of goods (eqv ISO 780: 1997)
GB/T 2828.1-2003 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (apply to inspection of process stability)
GB 9706.1 Medical electrical equipment - Part 1: General requirements for safety (GB 9706.1-2007, idt IEC 60601-1:1988)
GB/T 10050-1988 Optics and optical instruments - Reference wavelengths (eqv ISO 7944:1984)
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
JB/T 9328-1999 Resolving power test target
ISO 10526:1999 (E) CIE standard illuminants for colorimetry
3 Terms, definitions and classification
3.1 Terms and definitions
3.1.1
operation microscopes
stereomicroscope used for observation during surgical and other medical procedures, consisting of an optical system of observation, including objective lens, optical system with variable magnification, eyepiece tube and eyepieces as well as lighting system, stand and electrical device, with corresponding accessories configured according to different use requirements
3.1.2
working distance
working distance of operation microscopes may be classified into step working distance (focal length of large objective lens) or stepless working distance (automatic focusing of objective lens), with nominal values preferably calculated using Equation (1):
W=100+25n (1)
Where,
W——the working distance, mm;
n——an integer between 0 and 16.
3.2 Classification
Large objective lens operation microscope: a large objective lens is shared within the binocular optical path system of operation microscope; small objective lens operation microscope: the binocular optical path system of operation microscope is equipped with objective lens separately.
Contents of GB 11239.1-2005
Foreword i
1 Scope
2 Normative references
3 Terms, definitions and classification
4 Requirements
5 Inspection rules
6 Test methods
7 Marking, labeling and instructions for use
8 Packaging, transportation and storage
Annex A (Informative) Comparison between this part and ISO 10936.1: 2000 in clause/subclause number
Annex B (Informative) Technical differences between this part and ISO 10936.1: 2000 and their causes
