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GB 15193.24-2014: National Food Safety Standard -- Food Safety -- Requirements on Pathology Examination Technique in Toxicological Evaluation
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National Food Safety Standard -- Food Safety -- Requirements on Pathology Examination Technique in Toxicological Evaluation
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GB 15193.24-2014
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Basic data | Standard ID | GB 15193.24-2014 (GB15193.24-2014) | | Description (Translated English) | National Food Safety Standard -- Food Safety -- Requirements on Pathology Examination Technique in Toxicological Evaluation | | Sector / Industry | National Standard | | Classification of Chinese Standard | C53 | | Classification of International Standard | 67.020 | | Word Count Estimation | 7,757 | | Date of Issue | 12/1/2014 | | Date of Implementation | 5/1/2015 | | Regulation (derived from) | National Health and Family Planning Committee Announcement 2014 No. 19 | | Issuing agency(ies) | National Health and Family Planning Commission of the People's Republic of China | | Summary | This Standard specifies the food safety toxicology evaluation routine pathological examination technical requirements. This Standard applies to food safety toxicology evaluation routine pathological examination. | GB 15193.24-2014: National Food Safety Standard -- Food Safety -- Requirements on Pathology Examination Technique in Toxicological Evaluation
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(National food safety standards of food safety toxicology evaluation of pathology technical requirements)
Book People's Republic of China National Standard
National Food Safety Standard
Food safety toxicology evaluation of pathology
skills requirement
(To be issued)
Issued on. 2014-12-01
2015-05-01 implementation
People's Republic of China
National Health and Family Planning Commission released
Book GB 15193.24-2014
National Food Safety Standard
Food safety toxicology evaluation of pathology
skills requirement
1 Scope
This standard specifies the food safety toxicology evaluation routine pathological examination of the technical requirements.
This standard applies to food safety toxicology evaluation routine pathological examination.
Objective 2
By pathological examination of the technical requirements of regulations and standards inspection by the operator, reduce the deviation of test results, so histopathology
The results are more scientific, effective and conducive to the accumulation and comparison of scientific data between laboratories provide morphological food toxicology safety evaluation
Evaluating the evidence.
3 Terms and Definitions
3.1 general observation
Supplemented by the naked eye or using a magnifying glass, ruler and days equal tools Specimens and disease traits were observed and recorded findings of
process.
3.2 Sampling
Removal of the test animals at autopsy organs and tissues of all or part of the cut whichever representative lesion to use for pathological examination
specimen.
3.3 Fixed
The sample specimen is immersed in fixative, so that the material within the cells as close as possible the process of morphology and location of its living state.
3.4 coverage
Sampling from the pinned specimens in accordance with the purpose and requirements of the pathological process of tissue cut out of the appropriate size.
3.5 Dehydration
The fixed tissue repair after cutting through a series of substitutions dehydrating agent impregnated moisture in the tissue, so that the embedding medium can penetrate into the tissue
process.
3.6 Transparent
After tissue dehydration, and both are immersed in a dehydrating agent but also with embedding medium-miscible solvent in the process of embedding agent immersed tissue blocks.
Baptist wax 3.7
After the transparent tissue, in different melting points, density gradient melted paraffin impregnation process.
3.8 embedded
After soaked tissue penetration agents, (usually paraffin) package process is by embedding medium.
3.9 slices
Embedded tissue blocks after sliced on a slicer, adhesion process on a glass slide.
3.10 Dyeing
To determine the normal tissue or cell structure or lesion structure, using the corresponding display these dye components, through a series of special place
Li, the dye with the tissue or cell components, and to improve the observability of the specimen.
Pathological examination of the general requirements 4
4.1 personnel requirements
4.1.1 pathology staff by the head of pathology and pathology technical staff, pathology staff should have good professional ethics, science
Rigorous work attitude, be able to use our expertise to complete the job.
4.1.2 pathology responsible person should have a medical or veterinary pathology pathology background, with knowledge of pathology and pathological diagnosis empirical theory can be
To accurately read the piece were familiar with pathology reporting process and histopathological evaluation of tissue sections responsible, including the abnormal tissue changes Kam
Given and explained.
4.1.3 pathology technician should have a medical, veterinary or biological background, or experience relevant test, pathological examination after training, proficiency
Master the basic techniques of pathology. At work should be strictly implemented standardized technical procedures.
4.2 Accommodation and environmental conditions require
4.2.1 General pathology laboratory work area according to the quality control requirements should have a separate room or functional areas, including specimen storage room, drawing room,
Frozen section room (zone), conventional tabletting pretreatment (tissue dehydration, transparent, dipping wax, embedded) room (zone), conventional tabletting (sliced, stained, were mounted) room
(Region), histopathological diagnosis room, pathological data archives.
4.2.2 The laboratory shall have good ventilation and lighting equipment, emergency power supply and equipped with personal protective equipment sterilization, emergency care facilities.
4.2.3 pathological examination of the relevant equipment should be the appropriate inspection, maintenance, and other operations scrap management procedures.
4.3 Technical Requirements
4.3.1 Acceptance by the person responsible for pathological tissue inspection, check the relevant information and records.
4.3.2 pathology specimen preparation and examination process, should be strictly in accordance with the appropriate standard operating procedures (SOPs) to operate.
4.3.3 by a pathologist who is responsible for microscopic observation, understanding the pathology report issued before the trial-related information, including experimental design, by
Physical and chemical properties and biological activity of the test substance characteristics, given the way the test substance, the dose and duration of animal species, strain, weeks, clinical table
Now, biochemical and physiological indicators.
4.3.4 In order to obtain a reliable pathological findings, all tissue sections were evaluated with an animal testing required by the responsible person with a pathological Press
According to uniform standards, the pathological changes diagnosis and classification. The outer and inner body or bodies, if necessary by pathologist for review.
4.4 documents and records control requirements
Pathological examination shall be provided with the appropriate form of the test process and results of the complete records, and timely entry of electronic computer laboratory
Data recording system, to ensure the integrity, accuracy and traceability of the data.
5 pathology specific technical requirements
5.1 pathological examination should know before general clinical manifestations of experimental animals, and a corresponding record.
Number, group, sex, etc. of individual information needs to be 5.2 pathological anatomy examination of experimental animals have clear records.
5.3 before necropsy on the animal body surface should be carefully examined, including animal hair (dense or sparse, shiny, hair loss or contamination) and animal sticky surface
Membrane condition, skin and mucous membranes to observe whether there is visible pigment, keratosis, anemia, jaundice, edema, nodules, bleeding, bruising, trauma, erosion and
Ulcers and other abnormal changes. In the autopsy tissues and organs of the location, appearance, shape, color, texture and careful observation to determine whether the test substances lead
From animal tissues and organs pathological changes shape, size, color, texture and other aspects, whether pathological shift test animal chest
Cavity, abdominal cavity and pericardial fluid retention and whether there are traits (including color and transparency) changes.
5.4 removal of organs, should be standardized necropsy order. celiac autopsy, necropsy chest, pelvic autopsy, necropsy neck, body cavity organs removed
Organs and body cavities separating the naked eye, brain and spinal cord autopsy, and vertebral marrow necropsy performed. All the pathological changes seen in autopsy should be done in detail
Fine record, the need for pictures, video recording, if necessary. After removal of the stomach cut open along the greater curvature of the stomach, the stomach contents rinse with saline slurry stomach
After the film adheres to the cardboard into the fixative, the gut can be fixed neutral formalin solution perfusion mode. When sampling lobe
Need to cover a thin layer of cotton wool impregnated with fixative in the lung surface to prevent lung tissue fixative floating on the surface caused by insufficient fixed, if necessary,
Into the amount of neutral formalin solution from the bronchi. Solid renal tissue re-sampling along the midline toward the outer edge of the renal hilum direction to make a horizontal section
set. From the back of the liver, liver tissue sampling intervals along its long axis parallel to the rear longitudinal 1.5cm ~ 2.0cm cut fixed. Sampling along the heart
Coronal incision cleared off the clot after fixation. 24h after bone tissue fixation in neutral formalin solution for decalcifica-. To be done to disease
Li inspected sample specimens to avoid doing damage by external forces and equipment to the organization caused by the specimen sample size should be appropriate to the stationary phase can be filled
Sub-soaked center is appropriate.
5.5 pairs of death and dying during the test animal should be necropsied rapid removal of excised organs and tissues suitable specimen after fixation.
5.6 organs needs weighing before weighing should try to eliminate the surrounding adipose tissue and connective tissue, and organ tissues absorb with filter paper
Smaller organ surface blood and body fluids, especially the adrenal gland, thyroid, prostate, etc., should be removed immediately after weighing, prevent organ Drying
And weight loss. Luminal organs before weighing, should clear its cavity fluids, such as blood clots should be removed heart, gastrointestinal tract Rinse out the contents.
Paired organs and tissues to be weighed together, choose the appropriate balance weight according to organs and tissues, quickly weighed in accordance with the organization and the list of animal autopsy table
Removal of organs and tissues need to be checked after fixed promptly.
5.7 pathological specimens fixed sampling should select the appropriate fixative and fixation according to the characteristics of the tissue samples and test purposes, and should be fixed
When full, and as soon as possible drawn producer. Conventional neutral formalin fixative solution, depending on the particular pathology (special stains and organization
Need to learn staining, immunohistochemistry and in situ nucleic acid hybridization staining, electron microscopy, etc.) should be used in other suitable fixative.
Fixative and sample specimen volume ratio of at least was 4 to 1 is generally fixed time 48h ~ 72h.
5.8 pairs of experimental design required inspection organ or tissue derived, directions (section) to be consistent, cut from large tissue
Small suitable, structural integrity; undesired organs or parts appear abnormal, additional specimens should be retained, select the lesion center and the junction of the normal and pathological
Drawn at the organization; derived records to complete.
5.9 pathological examination of specimens stained according to the need to make the necessary pre-treatment of tissue necessary trimming after trimming a tissue
Like thickness should be 3mm ~ 5mm, organizations need trimmed after dehydration, transparent, and embedded processing such as dipping wax.
5.10 embedded tissue specimens should be smooth surface, slicing should cover all structures, tissues and organs in paraffin slice thickness is generally 3μm ~
5μm, to be taken at the same time for a variety of serial sections stained. When the maximum surface embedded tissue blocks or specially designated section of the tissue surface should
Under the same embedded in paraffin blocks of multiple small organizations should be located close to each other and located in the same plane, parietal, must be perpendicular to the skin and mucosal tissue
Embedded (buried upright). Producer Avoid artificial damage.
5.11 routine pathological examination generally paraffin sections and hematoxylin - eosin (H & E) staining, staining can increase if necessary (including
Diagnosis Related special staining), immunohistochemical staining for pathological examination.
5.12 Producer organization process, should ensure a consistent number of sections with a wax block number. Good tissue sections should include the full section of the subject organization, without
No fold marks, staining nucleoplasm distinct separation moderate, clean and transparent, sealed mounted appearance. After production is complete, pathology technician should slice therewith
Pathological examination of records should be drawn and work records be checked carefully, after confirmation, a good slice and corresponding records will be prepared
Handed over to the person in charge of pathology, both via the transfer after verification, for the transfer of the signing procedures.
5.13 pathology responsible for films to reading sections to conduct a comprehensive observation, animal numbers should read the piece or by organizational order, all biopsy specimens
One by one in order to be observed, described and recorded. Pathological findings described should be objective, detailed, comprehensive, image, pathology professionals should use the standard
Industry terminology, typical lesions should be meaningful picture recording. Differential diagnosis should be required to determine the nature of the special staining.
5.14 pairs of non-neoplastic lesions in the nature and scope can be semi-quantitative method to distinguish differences in morphological changes.
5.15 tumor pathology must be a clear distinction between hyperplasia, dysplasia, tumor-like hyperplasia and tumor types. Experimental observation of the results is divided into.
a) benign and malignant;
b) primary and secondary;
c) tumor incidence.
Quality control of pathology 6
6.1 To reduce the impact caused by the operation, and at necropsy production process should be used between the control group and the test group-cross manner.
6.2 should ensure appropriate coverage organizations, such as no visible lesions drawn parts, organs and tissues should be unified. Tissue sections should include organ
And the entire structure of the organization, made of slices required quality checks, such as when slicing failed, to retain the original and re-sliced producer, then producer have
Detail drawn, production records and other information.
6.3 pathology report observations should use the terminology described in detail.
6.4 The laboratory shall develop all aspects of the test corresponding standard operating procedures (SOPs).
6.5 reagent labels should be clear and unambiguous, buy reagents include a reagent name, concentration, and (or) purity, storage conditions, purchasers, purchase date
Period, batch number, date and other information Kaifeng use, shall include the preparation of reagents with the reagent concentration, preparation people, preparation date, expiry date and other information,
All reagents should be detailed usage records.
6.6 To avoid confusion animal tissue samples, sample specimen, paraffin, slicing the number using the same grading system identification number.
6.7 sampling specimens, wax block, slice should have an independent space temporarily saved and archived, standard pathology archives management after the end of the test in accordance with
Operating procedures archived.
7 pathological examination should pay attention to the problem
7.1 generally describes pathological autopsy. Gross anatomy of lesions found detailed records should be done, if necessary, use pictures or illustrations to mark
Characteristics of the lesion location, color, size, and other traits. Use descriptive language, do not use the term diagnosis.
7.2 Description of histopathological changes. Histopathological changes in the description shall include lesions located within the organs, tissues, lesions points
Cloth and scope, nature and extent of lesions and other lesions.
7.3 Use diagnostic terms. The term should be unified, clear, accurate and professional peer recognition, not coin the term.
7.4 pathological examination should take full account of the following factors.
Parts a) produced lesions, nature, extent, distribution;
b) the frequency and regularity of specificity compared with the control group appears in each dose group;
c) dose lesions and test substance - effect relationship;
d) pathological characteristics and treatment factors of structure-activity relationships;
e) when dealing with the course schedule and system factors;
f) examination results and necropsy lesions, organ tissue weight, animal clinical manifestations, biochemical blood test, urine test and special test between
Association;
g) human factors and disease caused by non-experimental factors;
h) the historical background and the background of this test (and historical controls this controls) and related knowledge as the basis for the differential diagnosis.
8 basic content pathology report
8.1 Title
Press "+ test animals administered the test substance was tested manner + name + toxicology test project" and other relevant information about the naming.
8.2 test substance and submission of information
Toxicology tests should include items such as the name of the test, the test substance number, unit inspection or submission human specimens fixed time, inspection time, moving
It was the source of animal strains, animal level, pathology number dyeing methods, reporting time and other information.
8.3 Objective
Histopathological changes and significance of this trial brief observation indexes.
8.4 Materials and Methods
It should include experimental animal species, number, group, organs and tissues name, quantity, reagents, instruments, production and dyeing methods.
8.5 Results
Application Language Pathology concluding summary description necropsy and histopathological findings.
8.5.1 Necropsy results. summary description language pathology concluding observed the appearance of the skin and organs and tissues caused by the test substance has
Meaning lesions.
8.5.2 Histopathological examination results. language pathology concluding summary description of the observed lesions caused by the test substance, the list of instructions
Lesions in the number of cases.
Death 8.5.3 during the test or the results of necropsy and histopathology dying animal summarized description and analysis of the cause of death.
8.6 discussion
If necessary, will be discussed.
8.7 Conclusion
All items should be given to check whether there is correlation between opinions and test substances.
8.8 Signature
Including human pathological examination, checking signatures and dated.
8.9 References
If necessary, are listed in references.
9 peer review
9.1 pathology general pathology by a person responsible for the completion of the report and read the piece, in exceptional cases, if the participation of a number of pathological tissue staff
Pathological observation results when there are differences, the unit should organize non-peer-reviewed.
9.2 Peer review comments as a reference, the final conclusion is determined by a pathologist in charge.
9.3 peer review comments as necessary after the annex attached to the report.
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